End to End Product Quality Management Lead

Job type: Full-Time
Accepting BioReady™: Yes
Category: General Management, Operations and Administration
Experience: 10+ Years
Employer: Sanofi
Location: Mississauga, ON
Posted: August 5, 2022
Closes: September 5, 2022

Job description:

Reference No.R2654912

Department: Quality & Operations

About Genzyme, a Sanofi Company

Sanofi Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day.  Sanofi Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Sanofi Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.sanofigenzyme.com.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Position Summary:

Leadership role fully accountable to drive product release activities to meet Customer Service needs as well as Health Canada quality and compliance requirements.  The role is also responsible for overseeing the Deviation, CAPA and Change control requirements for GMP functions.  Drives Ensures that the Canadian affiliate maintains the high quality and compliance status of all products handled by Sanofi Canada Inc. (including sanofi-aventis, Sanofi Consumer Health and Sanofi Genzyme divisions) while meeting Canadian cGMP regulations as well as Corporate requirements.  The role is responsible for liaising directly with Quality Heads of 30+ manufacturing sites to escalate and ensure Quality and Compliance requirements are being satisfied such that Customer Service needs can be met.

Key Responsibilities:

• Oversee all Quality aspect supporting lot release of imported finished goods and periodic compliance requirements such as executed batch record review, stability review, confirmatory testing etc.

• Oversee the testing program, as per Canadian GMPs including investigation of Out of Specification results, defining resulting market actions and liaising with Global Quality teams for alignment and Corporate approvals.

• Oversee the Release of broad portfolio of Commercial products as well as the Release for SAP, Clinical  Material  and Access to  Drugs in Exceptional Circumstances.

• Management of temperature excursions to ensure additional Health Canada requirements are met with respect to highly technical product impact assessments to support product disposition decisions.

• API release management.

• Responsible to manage the Sanofi Canada Quality relationship with the Sanofi External Manufacturing Quality.

• Approve assessment and disposition of returned products in support of eligibility to be returned to stock.

• Oversees Quality management of supply chain to ensure API and Finished Good manufacturing/packaging partners are operating within a state of control, are aware of and compliant to Health Canada regulations and have robust programs in place to identify/implement CAPAs.

• Maintain and continuously improve the GMP Quality System related to product quality.

• Provide quality leadership and supervision of QA staff and external consultants.

• Serve in a backup capacity to the Country Quality Head and also to other Quality Leads for their respective responsibilities.

• Participate in recall processes, as required.

• Participate in regulatory inspections (Health Canada), as well as internal and corporate audits.

• Keep abreast of existing and new Health Canada guidelines and policies, industry best practices with respect to Quality Assurance, and corporate policies and procedures.

• Strategic support of product quality related activities for new product launches to ensure supply continuity and launch readiness.

• Identify and independently lead the team to act on compliance gaps or continuous improvement projects.

• Create, review and/or approve SOPs, protocols, and other technical documents, as applicable.

• Continuously improve processes to ensure Canadian GMP requirements are met in a robust and streamlined manner.

• Support Quality Performance Indicators for QA activities and maintain ownership for performance against indicators.

Key Requirements:

• Must hold a university degree; this must be a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.*

• *Persons applying for positions in QA must provide evidence of qualifications, as outlined in Good Manufacturing Practices (GMP) Guidelines – 2018 current, for review and assessment by the Head of Quality or designate, as a condition of any offers of employment.

• 15+ years in pharmaceutical industry (QA, QC, Production or equivalent).

• Strong understanding of Canadian GMPs related to Importation and Distribution with direct experience hosting Regulatory inspections

• skills.

• Excellent analytical and problem-solving abilities.

• Team leadership to develop people and collaboration.

• Ability to maintain good interpersonal relationships.

• Ability to manage significant complexity and adapt to changing business models.

• Ability to set and manage competing priorities to ensure deliverables are met.

• Strong communication skills (verbal and written).

• Strong ability to influence without authority.

• Strongly oriented towards delivery, performance and accountability.

• Strong ability to follow up and effectively escalate.

• Highly technical and computer savvy (eg. ERP proficiency).

• ERP/SAP systems, MS Office, Adobe Suite, generally strong, demonstrated proficiency.

Languages:

• English:  Excellent knowledge (reading, writing and oral).

• French:  Written and spoken proficiency an asset.

Travel:

• Occasional.

HSE RESPONSABILITIES

Managers at Head Office and Distribution Center

Show support for the protection of health, safety and the environment by presenting exemplary behavior and by contributing to the HSE objectives achievement.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

#GD-SG#LI-GZ

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Apply Now