Head of Quality Compliance

Sanofi•Framingham, MA

6d•$161,250 - $232,917•Onsite

About The Position

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 the completion of Quality Compliance-related activities. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

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.)
Proficient in computer software programs and applications.
Effective communication skills (listening, verbal and written).
Ability to collaborate across functions and throughout all levels.
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, use of digital systems in manufacturing operations.
Project Management skills and knowledge.
Proven record in executing and delivering results.
Equipment and process validation in 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).
Leading and managing the compliance team, including hiring, training, coaching, professional development and performance evaluation.
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 of managing internal audits and hosting external regulatory inspections from health authorities, including preparation, execution, and follow-up
A thorough knowledge and understanding of the pharmaceutical industry and the 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.

Nice To Haves

Special Working Conditions: Ability to gown and gain entry to controlled, classified areas

Responsibilities

Developing, implementing, and maintaining an effective compliance program
Ensuring that the Site complies with all laws, regulations, and standards applicable in the pharmaceutical industry
Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters
Maintaining a system to ensure compliance and quality risks are properly identified, tracked and mitigated
Ensuring 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.
Establishing and monitoring key performance indicators (KPIs) and metrics for the site compliance, and reporting 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 the site compliance fostering a culture of compliance
Leading and managing the compliance team, including hiring, training, coaching, professional development and performance evaluation.