Head of Quality Compliance

About the role

The Quality Assurance Department is responsible for providing oversight on all GMP activities and related functions associated with the manufacture and release of biological products at the site. The department manages the compliance program for the Framingham Biologics, Framingham Biosurgery, and Northborough sites (e.g., Self Inspection, Dossier Compliance, External Inspections) and provides site metrics to determine site performance against Quality Metric Indicators. The department’s goal is to ensure that policies, procedures, and processes are in place so that all site Quality Management System activities meet applicable regulations while allowing for monitoring the progress and completion of Quality Compliance-related activities.

Responsibilities

• Develop, implement, and maintain an effective compliance program.
• Ensure the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry.
• Establish and maintain effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and represent the company in compliance-related matters.
• Maintain a system to ensure compliance and quality risks are properly identified, tracked, and mitigated.
• Ensure the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance.
• Ensure that any compliance issues are reported to the relevant authorities in a timely manner.
• Manage and resolve any compliance issues or allegations that arise and take appropriate corrective and preventive actions.
• Establish and monitor key performance indicators (KPIs) and metrics for site compliance, and report on the results to management.
• Host the Business Owners self-inspection and other key systems.
• Identify and drive continuous improvement initiatives and projects to enhance site compliance, fostering a culture of compliance.
• Lead and manage the compliance team, including hiring, training, coaching, professional development, and performance evaluation.

Leadership Skills

• Commitment to conducting global business according to the highest legal and ethical standards, and continually pursuing excellence in the development and delivery of all products and services.
• Adherence to all applicable laws and regulations, as well as company policies and procedures.
• Honesty and treating people with respect and courtesy.
• Striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
• Acting as a role model by acting responsibly, fairly, and honestly in dealings and exercising sound judgment.
• Motivating, inspiring, building, and retaining highly effective manufacturing teams while managing for high performance and developing others.
• Versatility in learning and courage in decision-making.
• Effectiveness in operating in an evolving, complex, and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking for best practices and areas for improvement.
• Understanding patient and customer needs and building relationships to meet manufacturing goals while continuously improving operations by setting high standards for the team.

Requirements

• Bachelor’s degree in a science or equivalent with 10+ years of experience or Master’s degree with 8+ years’ experience working in a cGMP regulated industry (human pharmaceutical drug, vaccines, and/or biologics).
• 8+ years’ experience managing people/projects or related experience influencing others.
• Experience with hosting and managing regulatory inspections (PAI, General GMP, For-Cause inspections, etc.).
• Broad working knowledge of cGMP and pharmaceutical regulatory requirements (21-CFR Part 11, 210 & 211, 600, 610); EU-GMP and EU Annex, ISO, ICH guidelines, PIC/s.
• In-depth knowledge of the systems-based inspection approach to regulatory inspections.
• Understanding of aseptic processing, use of SUT as a manufacturing platform, and use of digital systems in manufacturing operations.
• Project management skills and knowledge.
• Proven record in executing and delivering results.
• Experience with equipment and process validation in a cGMP environment.
• Knowledge of Total Quality Management (TQM), ISO, Six-Sigma, etc.
• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH).
• Proficient in computer software programs and applications.
• Effective communication skills (listening, verbal, and written).
• Ability to collaborate across functions and throughout all levels.
• Demonstrated problem-solving skills.
• Extensive experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Proven experience managing internal audits and hosting external regulatory inspections from health authorities, including preparation, execution, and follow-up.
• Thorough knowledge and understanding of the pharmaceutical industry and applicable laws, regulations, and standards.
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions.
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders.
• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards.
• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports.

Special Working Conditions

• Ability to gown and gain entry to controlled, classified areas.

Benefits

• Discover endless opportunities to grow your talent and drive your career, whether through promotion or lateral move, at home or internationally.
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.