Head of Quality Compliance

Sanofi•Framingham, MA

14h•$133,500 - $192,833•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 with 10+ years of experience working in a cGMP regulated industry (human pharmaceutical drug, vaccines, and/or biologics). OR Master's degree with minimum of 8+ years of experience working in a cGMP regulated industry (human pharmaceutical drug, vaccines, and/or biologics).
Experience managing others.
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.
Experience with hosting and managing regulatory inspections (PAI, General GMP, For-Cause inspections, etc.)
Proven record in executing and delivering results.
In-depth knowledge of the systems-based inspection approach to regulatory inspections.
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.
Project Management skills and knowledge
Understanding of Aseptic processing, use of SUT as a manufacturing platform, use of digital systems in manufacturing operations.
Equipment and process validation in cGMP environment.
Knowledge of Total Quality Management (TQM), ISO, Six-Sigma, etc.

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.
Is or 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