EVERSANA
VP, Quality Assurance & Regulatory Compliance
Position overview: The VP, Quality Assurance & Regulatory Compliance is responsible for establishing strategies, planning and development of quality and regulatory compliance processes and procedures to ensure EVERSANA is compliant with applicable federal, state, and local regulations and standards, with a focus on Quality & Regulatory. This role manages and directs the activities of the Quality & Regulatory Departments to ensure the company's processes and services meet regulatory requirements and quality standards.
Responsibilities
Oversee Quality Assurance, set quality goals and objectives aligned with business unit goals and applicable standards (FDA/DEA, State Boards Pharmacy, Accredited Bodies, GDP and ISO Quality Standards).
Promote a company-wide culture of quality awareness and understanding of quality system and regulatory compliance requirements.
Serve as the Quality management representative for regulators, notified bodies and customer audits.
Maintain knowledge of existing and emerging quality standards and regulations; interpret changes and communicate them through corporate policies and supplier agreements.
Own audit processes for Supplier Qualification and Maintenance; facilitate Supplier Selection across functions and external partners.
Lead selection and qualification of GxP suppliers and manage corresponding quality agreements.
Collaborate with SMEs to ensure expert technical review of controlled documents; review and approve GxP-related documentation including deviations, OOS investigations, CAPAs, risk assessments, etc.
Create and maintain a quality documentation system; write and update QA procedures.
Support Qualified Suppliers in development of protocols for method validations, verifications, validations, biocompatibility, sterilization, shelf life, stability, and risk management.
Develop the Quality Assurance Unit by recruiting, selecting, orienting, and training QA staff.
Plan, monitor, and appraise QA staff performance and results.
Provide leadership in the establishment of regulatory compliance strategies and processes at the business level.
Regulatory Responsibilities
Drive implementation and ongoing compliance with global regulatory requirements; interpret laws and regulations to meet business objectives.
Lead development, implementation, and maintenance of regulatory processes; support regulatory compliance strategies.
Coordinate regulatory submissions across facilities; serve as main channel with regulatory authorities or work with consultants/clients to ensure compliance.
Monitor regulatory environment and communicate impacts of changes; ensure training and policies reflect new regulations.
Represent Regulatory function on project teams to align regulatory strategy with objectives.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
People Leader Lead and develop the Quality Assurance & Regulatory Compliance teams. Responsibilities include strategy, staffing, performance management, quality culture, regulatory oversight, and ensuring compliant activities across all regulated work.
Establish Quality and Regulatory Compliance strategies aligned with Business Units objectives.
Recruit, supervise and develop department staff; ensure policy and procedure adherence.
Promote a culture of quality awareness and regulatory compliance.
Oversee all regulated activities to meet federal, state and local regulations.
Improve the quality management system, documentation, and regulatory compliance through continuous improvement.
Lead regulatory inspections and responses to regulatory letters and observations where applicable.
Ensure contracted services comply with governing regulations and client requirements.
Expectations of the Job
Travel: 25%
Hours: 40-hour work week
Qualifications Minimum Knowledge, Skills and Abilities The requirements below are representative of the experience, education, knowledge, skills and/or abilities required.
Education: Bachelor’s degree in Life Sciences or a related field.
Experience/Training:
15+ years of experience in Quality and Regulatory Compliance.
7+ years of recent management experience in a regulated healthcare products environment with project management skills.
Experience managing Quality and Regulatory Compliance requirements in pharmaceutical, medical device, or biologics industries.
Track record of implementing and managing quality standards; leading QA/RA teams for complex products.
Experience with all aspects of GxP regulations.
Ability to manage multiple priorities in a fast-paced environment.
Licenses/Certificates: Two or more ASQ certifications.
Technology/Equipment: Microsoft Office Suite (Word, Excel, PowerPoint).
Continuous Improvement Tools: Six Sigma or LEAN.
Communication: Ability to articulate ideas clearly and motivate others.
Innovator: Turns creative ideas into practical solutions.
Principled: High integrity and professional ethics.
Preferred Qualifications
Education: Master’s degree in Life Sciences or a related field.
Licensure: Federal and State licenses as applicable.
Product Categories: Specialty, Cold Chain, Controlled Substances, Biologics (Tissue Bank), and Combo Devices.
Project Management: 10+ years of quality & regulatory compliance oversight.
Performance Indicators: 10+ years of data analysis, trend analysis and KPIs.
Experience as Life Sciences service provider with regulatory consulting.
ASQ Management and Lead Auditor certifications.
Physical/Mental Demands and Working Environment Office environment; ability to sit or stand for long periods, occasional lifting up to 25 pounds; typical noise level is moderately quiet.
Additional Information Our cultural beliefs include Patient Minded, Client Delight, Take Action, Grow Talent, Win Together, Communication Matters, Embrace Diversity, and Always Innovate. We are an Equal Opportunity Employer and provide reasonable accommodations as required by law. EVERSANA has no tolerance for recruitment fraud and will never request personal information or payment during the employment process. If reasonable accommodation is needed, please contact applicantsupport@eversana.com. Follow us on LinkedIn | Twitter.
#J-18808-Ljbffr
Responsibilities
Oversee Quality Assurance, set quality goals and objectives aligned with business unit goals and applicable standards (FDA/DEA, State Boards Pharmacy, Accredited Bodies, GDP and ISO Quality Standards).
Promote a company-wide culture of quality awareness and understanding of quality system and regulatory compliance requirements.
Serve as the Quality management representative for regulators, notified bodies and customer audits.
Maintain knowledge of existing and emerging quality standards and regulations; interpret changes and communicate them through corporate policies and supplier agreements.
Own audit processes for Supplier Qualification and Maintenance; facilitate Supplier Selection across functions and external partners.
Lead selection and qualification of GxP suppliers and manage corresponding quality agreements.
Collaborate with SMEs to ensure expert technical review of controlled documents; review and approve GxP-related documentation including deviations, OOS investigations, CAPAs, risk assessments, etc.
Create and maintain a quality documentation system; write and update QA procedures.
Support Qualified Suppliers in development of protocols for method validations, verifications, validations, biocompatibility, sterilization, shelf life, stability, and risk management.
Develop the Quality Assurance Unit by recruiting, selecting, orienting, and training QA staff.
Plan, monitor, and appraise QA staff performance and results.
Provide leadership in the establishment of regulatory compliance strategies and processes at the business level.
Regulatory Responsibilities
Drive implementation and ongoing compliance with global regulatory requirements; interpret laws and regulations to meet business objectives.
Lead development, implementation, and maintenance of regulatory processes; support regulatory compliance strategies.
Coordinate regulatory submissions across facilities; serve as main channel with regulatory authorities or work with consultants/clients to ensure compliance.
Monitor regulatory environment and communicate impacts of changes; ensure training and policies reflect new regulations.
Represent Regulatory function on project teams to align regulatory strategy with objectives.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
People Leader Lead and develop the Quality Assurance & Regulatory Compliance teams. Responsibilities include strategy, staffing, performance management, quality culture, regulatory oversight, and ensuring compliant activities across all regulated work.
Establish Quality and Regulatory Compliance strategies aligned with Business Units objectives.
Recruit, supervise and develop department staff; ensure policy and procedure adherence.
Promote a culture of quality awareness and regulatory compliance.
Oversee all regulated activities to meet federal, state and local regulations.
Improve the quality management system, documentation, and regulatory compliance through continuous improvement.
Lead regulatory inspections and responses to regulatory letters and observations where applicable.
Ensure contracted services comply with governing regulations and client requirements.
Expectations of the Job
Travel: 25%
Hours: 40-hour work week
Qualifications Minimum Knowledge, Skills and Abilities The requirements below are representative of the experience, education, knowledge, skills and/or abilities required.
Education: Bachelor’s degree in Life Sciences or a related field.
Experience/Training:
15+ years of experience in Quality and Regulatory Compliance.
7+ years of recent management experience in a regulated healthcare products environment with project management skills.
Experience managing Quality and Regulatory Compliance requirements in pharmaceutical, medical device, or biologics industries.
Track record of implementing and managing quality standards; leading QA/RA teams for complex products.
Experience with all aspects of GxP regulations.
Ability to manage multiple priorities in a fast-paced environment.
Licenses/Certificates: Two or more ASQ certifications.
Technology/Equipment: Microsoft Office Suite (Word, Excel, PowerPoint).
Continuous Improvement Tools: Six Sigma or LEAN.
Communication: Ability to articulate ideas clearly and motivate others.
Innovator: Turns creative ideas into practical solutions.
Principled: High integrity and professional ethics.
Preferred Qualifications
Education: Master’s degree in Life Sciences or a related field.
Licensure: Federal and State licenses as applicable.
Product Categories: Specialty, Cold Chain, Controlled Substances, Biologics (Tissue Bank), and Combo Devices.
Project Management: 10+ years of quality & regulatory compliance oversight.
Performance Indicators: 10+ years of data analysis, trend analysis and KPIs.
Experience as Life Sciences service provider with regulatory consulting.
ASQ Management and Lead Auditor certifications.
Physical/Mental Demands and Working Environment Office environment; ability to sit or stand for long periods, occasional lifting up to 25 pounds; typical noise level is moderately quiet.
Additional Information Our cultural beliefs include Patient Minded, Client Delight, Take Action, Grow Talent, Win Together, Communication Matters, Embrace Diversity, and Always Innovate. We are an Equal Opportunity Employer and provide reasonable accommodations as required by law. EVERSANA has no tolerance for recruitment fraud and will never request personal information or payment during the employment process. If reasonable accommodation is needed, please contact applicantsupport@eversana.com. Follow us on LinkedIn | Twitter.
#J-18808-Ljbffr