Endo
Join to apply for the
Sr Dir Quality
role at
Endo
We want the best and brightest people to help us achieve our mission to develop and deliver life‑enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary The Sr. Director, Quality is responsible for a broad range of duties/functions that includes all Quality functions at the St. Louis Plant, and the Centers of Excellence for Microbiology, Elemental Impurities, and Validation, to support the Generics Business. The role ensures cGMP compliance and product quality at the Saint Louis, MO facility while supporting broader site quality initiatives aligned with company objectives. This role provides strategic leadership in the development, implementation, and oversight of site quality systems to ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Sr. Director leads and mentors quality assurance and quality control teams, oversees daily quality operations, and serves as a key partner to site leadership by providing guidance on quality and compliance across the organization.
Job Description – St. Louis Plant Quality Responsible for developing, establishing, and maintaining quality systems programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. Serve as liaison between the company and the various governmental agencies. Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues.
Implement and maintain compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error, salvage, spoilage reports and process statistics for significant findings and conclusions.
Collaborate with Research and Development during new product start‑ups, establishing key checkpoints for new products and processes.
Centers of Excellence for Microbiology, Elemental Impurities, and Validation The Sr. Director is responsible for Centers of Excellence for Microbiology, Elemental Impurities, and Validation to support the Generics Business. Develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service. Establish and maintain positive and mutually rewarding relationships with internal and external customers of the department. The Sr. Director will also oversee and manage the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.
Essential Functions – St. Louis Plant Quality Departments
Manages all aspects of plant Quality Systems including CAPA, Supplier Quality, Change Control, in‑process Quality Assurance, Quality Control, complaint management and validation functions.
Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.
Responsible to make fact‑based, scientifically sound, quality decisions regarding products manufactured at the St. Louis Plant facility within the requirements of cGMPs and applicable regulatory/industry guidance documents.
Manage approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents.
Ensure evaluation of batch records and that all necessary testing is carried out.
Approve specifications, sampling instructions, test methods and other QC procedures.
Ensure the authorization of all controlled documents, including records retention.
Ensure the monitoring and control of the manufacturing and Quality Control environments.
Ensure compliance with cGMP standards.
Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance both for Corporate and for applicable regulatory agencies.
Coach and develop the team to high performance while fostering a culture of team ownership.
Ensure team compliance with all policies, procedures and site/company regulations.
Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
Exhibit accountability and responsibility for an area or process to affect change and lead efforts and ideas to completion.
Provide leadership for employee relations through effective communication, coaching, training and development and eliminate roadblocks to enable the team to move forward.
Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
Lead the team in continuous improvement activities and take control when faced with adversity while incorporating team input.
Ensure proper maintenance and cleanliness of the department, premises and equipment.
Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
Lead and/or support investigations. Author, approve and review area quality and safety exceptions and investigation reports. Ensure on‑time completion of all corrective action items assigned to area.
Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
Identify opportunities to reduce costs, reduce risk and improve service.
Centers of Excellence – Additional Responsibilities
Develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service.
Establish and maintain positive and mutually rewarding relationships with internal and external customers of the department.
Responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.
General
Budget creation and management for Quality and Training Departments (>$15 MM).
Defines requirements of department personnel and works with Human Resources to hire such personnel.
Acts as subject matter expert and lead with internal and external regulatory inspections and audits of manufacturing sites in the area of Quality Systems, and Training.
Interfaces with FDA and regulatory agencies outside the US for events that include but are not limited to: manufacturing site inspections, Field Actions, and Recalls.
Perform other duties as assigned.
Minimum Requirements Education:
Bachelor's degree in chemistry, microbiology or similar life sciences or technical field such as engineering, mathematics, etc.
Experience:
Minimum of 15 years of pharmaceutical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of bulk drug substances, and solid dosage form drug products.
Minimum 5 years managerial experience in a pharmaceutical quality/regulatory affairs environment.
Preferred Skills/Qualifications
Previous experience serving as a pharmaceutical manufacturing site leader of a significant quality function (Total Plant population >500 persons, Quality Function >100 persons).
Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports.
Knowledge of FDA and International regulations and guidelines in the area of Quality Systems for pharmaceutical products and medical devices.
Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host.
Strong patient and customer focus.
Skills/Competencies
Strong writing skills to effectively communicate technical/clinical information to others.
Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.
Superior verbal communication skills including impeccable telephone etiquette.
Scientific literature searching and evaluation skills.
Organizational Relationships / Scope This position reports to the Head of Quality. It will have frequent communication and working relationships with USA manufacturing plant management and QA/RA personnel. Contact with regulatory authorities, state, federal and international is common.
Working Conditions This Position works primarily in an office environment. Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required. Will require occasional periods in the manufacturing areas and walking throughout the plants. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. When in manufacturing areas, PPE is required to be worn. Approximately 10–15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off‑site business meetings and professional training seminars and conferences.
Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
EEO Statement We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Endo by 2x
Get notified about new Senior Quality Specialist jobs in St Louis, MO.
St Louis, MO $110,000.00‑$230,000.00 1 week ago
St Louis, MO $125,000.00‑$125,000.00 1 day ago
St Louis, MO $67,362.50‑$87,175.00 2 weeks ago
Madison, IL $60,000.00‑$70,000.00 3 weeks ago
Edwardsville, IL $99,600.00‑$124,500.00 2 weeks ago
Edwardsville, IL $99,600.00‑$124,500.00 1 month ago
St Louis, MO $76,400.00‑$100,000.00 12 hours ago
Alorton, IL $124,000.00‑$155,000.00 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Sr Dir Quality
role at
Endo
We want the best and brightest people to help us achieve our mission to develop and deliver life‑enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary The Sr. Director, Quality is responsible for a broad range of duties/functions that includes all Quality functions at the St. Louis Plant, and the Centers of Excellence for Microbiology, Elemental Impurities, and Validation, to support the Generics Business. The role ensures cGMP compliance and product quality at the Saint Louis, MO facility while supporting broader site quality initiatives aligned with company objectives. This role provides strategic leadership in the development, implementation, and oversight of site quality systems to ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Sr. Director leads and mentors quality assurance and quality control teams, oversees daily quality operations, and serves as a key partner to site leadership by providing guidance on quality and compliance across the organization.
Job Description – St. Louis Plant Quality Responsible for developing, establishing, and maintaining quality systems programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. Serve as liaison between the company and the various governmental agencies. Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues.
Implement and maintain compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error, salvage, spoilage reports and process statistics for significant findings and conclusions.
Collaborate with Research and Development during new product start‑ups, establishing key checkpoints for new products and processes.
Centers of Excellence for Microbiology, Elemental Impurities, and Validation The Sr. Director is responsible for Centers of Excellence for Microbiology, Elemental Impurities, and Validation to support the Generics Business. Develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service. Establish and maintain positive and mutually rewarding relationships with internal and external customers of the department. The Sr. Director will also oversee and manage the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.
Essential Functions – St. Louis Plant Quality Departments
Manages all aspects of plant Quality Systems including CAPA, Supplier Quality, Change Control, in‑process Quality Assurance, Quality Control, complaint management and validation functions.
Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.
Responsible to make fact‑based, scientifically sound, quality decisions regarding products manufactured at the St. Louis Plant facility within the requirements of cGMPs and applicable regulatory/industry guidance documents.
Manage approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents.
Ensure evaluation of batch records and that all necessary testing is carried out.
Approve specifications, sampling instructions, test methods and other QC procedures.
Ensure the authorization of all controlled documents, including records retention.
Ensure the monitoring and control of the manufacturing and Quality Control environments.
Ensure compliance with cGMP standards.
Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance both for Corporate and for applicable regulatory agencies.
Coach and develop the team to high performance while fostering a culture of team ownership.
Ensure team compliance with all policies, procedures and site/company regulations.
Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
Exhibit accountability and responsibility for an area or process to affect change and lead efforts and ideas to completion.
Provide leadership for employee relations through effective communication, coaching, training and development and eliminate roadblocks to enable the team to move forward.
Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
Lead the team in continuous improvement activities and take control when faced with adversity while incorporating team input.
Ensure proper maintenance and cleanliness of the department, premises and equipment.
Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
Lead and/or support investigations. Author, approve and review area quality and safety exceptions and investigation reports. Ensure on‑time completion of all corrective action items assigned to area.
Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
Identify opportunities to reduce costs, reduce risk and improve service.
Centers of Excellence – Additional Responsibilities
Develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service.
Establish and maintain positive and mutually rewarding relationships with internal and external customers of the department.
Responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.
General
Budget creation and management for Quality and Training Departments (>$15 MM).
Defines requirements of department personnel and works with Human Resources to hire such personnel.
Acts as subject matter expert and lead with internal and external regulatory inspections and audits of manufacturing sites in the area of Quality Systems, and Training.
Interfaces with FDA and regulatory agencies outside the US for events that include but are not limited to: manufacturing site inspections, Field Actions, and Recalls.
Perform other duties as assigned.
Minimum Requirements Education:
Bachelor's degree in chemistry, microbiology or similar life sciences or technical field such as engineering, mathematics, etc.
Experience:
Minimum of 15 years of pharmaceutical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of bulk drug substances, and solid dosage form drug products.
Minimum 5 years managerial experience in a pharmaceutical quality/regulatory affairs environment.
Preferred Skills/Qualifications
Previous experience serving as a pharmaceutical manufacturing site leader of a significant quality function (Total Plant population >500 persons, Quality Function >100 persons).
Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports.
Knowledge of FDA and International regulations and guidelines in the area of Quality Systems for pharmaceutical products and medical devices.
Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host.
Strong patient and customer focus.
Skills/Competencies
Strong writing skills to effectively communicate technical/clinical information to others.
Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.
Superior verbal communication skills including impeccable telephone etiquette.
Scientific literature searching and evaluation skills.
Organizational Relationships / Scope This position reports to the Head of Quality. It will have frequent communication and working relationships with USA manufacturing plant management and QA/RA personnel. Contact with regulatory authorities, state, federal and international is common.
Working Conditions This Position works primarily in an office environment. Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required. Will require occasional periods in the manufacturing areas and walking throughout the plants. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. When in manufacturing areas, PPE is required to be worn. Approximately 10–15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off‑site business meetings and professional training seminars and conferences.
Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
EEO Statement We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Endo by 2x
Get notified about new Senior Quality Specialist jobs in St Louis, MO.
St Louis, MO $110,000.00‑$230,000.00 1 week ago
St Louis, MO $125,000.00‑$125,000.00 1 day ago
St Louis, MO $67,362.50‑$87,175.00 2 weeks ago
Madison, IL $60,000.00‑$70,000.00 3 weeks ago
Edwardsville, IL $99,600.00‑$124,500.00 2 weeks ago
Edwardsville, IL $99,600.00‑$124,500.00 1 month ago
St Louis, MO $76,400.00‑$100,000.00 12 hours ago
Alorton, IL $124,000.00‑$155,000.00 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr