Mallinckrodt Pharmaceuticals
Job Title
Sr. Director, Quality
Location
St. Louis, MO
Recruitment Information
Requisition: JR000015224 Sr Dir Quality (Open)
Position 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 Sr. Director 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 Senior 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.
Responsibilities
Manages all aspects of plant Quality Systems including CAPA, Supplier Quality, Change Control, in-process Quality Assurance, Quality Control, complaint management and validation functions.
Supports an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies. Creates and maintains an environment of excellence, world‑class quality and continuous improvement throughout the entire plant.
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.
Manages approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents.
Ensures the evaluation of batch records and that all necessary testing is carried out; approves specifications, sampling instructions, test methods and other QC procedures.
Ensures the authorization of all controlled documents, including records retention; monitors and controls the manufacturing and Quality Control environments.
Ensures compliance with cGMP standards and that 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.
Coaches and develops the team to high performance while fostering a culture of team ownership. Provides leadership for employee relations through effective communications, coaching, training and development and eliminates roadblocks to move the team forward.
Supplies the highest level of internal and external customer service while maintaining diplomatic challenge of established procedures and systems.
Leads and/or supports investigations, authorizes and reviews area quality and safety exceptions and investigation reports, ensures on‑time completion of corrective action items.
Verifies, reviews and makes appropriate changes to any controlled document pertinent to the area of responsibility. Identifies opportunities to reduce costs, reduce risk and improve service.
Develops policy, creates systems, establishes strategies and minimizes costs while striving for excellence in customer service for the Centers of Excellence for Microbiology, Elemental Impurities, and Validation.
Oversees and manages the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.
Creates and manages the budget for Quality and Training Departments (>$15MM). Defines requirements for department personnel and works with Human Resources to hire such personnel.
Acts as subject‑matter expert and leads 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 including manufacturing site inspections, field actions and recalls.
Qualifications
Minimum 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.
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.
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. Scientific literature searching and evaluation skills.
Ability to use various software programs (Word, Excel, PowerPoint, Access) and a willingness to expand and increase these competencies. Superior verbal communication skills including impeccable telephone etiquette.
Working Conditions
This position works primarily in an office environment. The individual must be able to sit for long periods and occasionally lift up to 10 pounds. Manufacturing areas may require walking throughout the plants, wearing PPE, and representing non‑climate‑controlled environments. Approximately 10–15% domestic travel and occasional international travel for site visits, off‑site meetings and training seminars is required.
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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Sr. Director, Quality
Location
St. Louis, MO
Recruitment Information
Requisition: JR000015224 Sr Dir Quality (Open)
Position 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 Sr. Director 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 Senior 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.
Responsibilities
Manages all aspects of plant Quality Systems including CAPA, Supplier Quality, Change Control, in-process Quality Assurance, Quality Control, complaint management and validation functions.
Supports an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies. Creates and maintains an environment of excellence, world‑class quality and continuous improvement throughout the entire plant.
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.
Manages approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents.
Ensures the evaluation of batch records and that all necessary testing is carried out; approves specifications, sampling instructions, test methods and other QC procedures.
Ensures the authorization of all controlled documents, including records retention; monitors and controls the manufacturing and Quality Control environments.
Ensures compliance with cGMP standards and that 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.
Coaches and develops the team to high performance while fostering a culture of team ownership. Provides leadership for employee relations through effective communications, coaching, training and development and eliminates roadblocks to move the team forward.
Supplies the highest level of internal and external customer service while maintaining diplomatic challenge of established procedures and systems.
Leads and/or supports investigations, authorizes and reviews area quality and safety exceptions and investigation reports, ensures on‑time completion of corrective action items.
Verifies, reviews and makes appropriate changes to any controlled document pertinent to the area of responsibility. Identifies opportunities to reduce costs, reduce risk and improve service.
Develops policy, creates systems, establishes strategies and minimizes costs while striving for excellence in customer service for the Centers of Excellence for Microbiology, Elemental Impurities, and Validation.
Oversees and manages the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.
Creates and manages the budget for Quality and Training Departments (>$15MM). Defines requirements for department personnel and works with Human Resources to hire such personnel.
Acts as subject‑matter expert and leads 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 including manufacturing site inspections, field actions and recalls.
Qualifications
Minimum 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.
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.
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. Scientific literature searching and evaluation skills.
Ability to use various software programs (Word, Excel, PowerPoint, Access) and a willingness to expand and increase these competencies. Superior verbal communication skills including impeccable telephone etiquette.
Working Conditions
This position works primarily in an office environment. The individual must be able to sit for long periods and occasionally lift up to 10 pounds. Manufacturing areas may require walking throughout the plants, wearing PPE, and representing non‑climate‑controlled environments. Approximately 10–15% domestic travel and occasional international travel for site visits, off‑site meetings and training seminars is required.
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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr