QA Operations Manager, PCU Lead

Main Responsibilities

• Quality Assurance Management:
• Develop and implement annual quality assurance objectives for E&M/Distribution manufacturing, aligning with organizational strategy and vision.
• Ensure compliance with GMP, regulatory requirements, and company quality standards for all E&M/Distribution production activities.
• Maintain a system to identify, track, and mitigate quality risks in E&M/Distribution manufacturing.
• Oversee batch release processes, including release of batches for further manufacturing and ensuring timely and compliant final disposition of completed batches.
• Lead investigations into quality issues, deviations, and out-of-specification results related to E&M/Distribution.
• Support other duties as required.
• Process-Centric Unit Management:
• Collaborate closely with production teams to maintain quality standards throughout the E&M/Distribution ecosystem.
• Conduct regular audits of E&M/Distribution processes to identify and address potential quality issues.
• Oversee all investigations related to E&M/Distribution production to ensure proper risk assessment and product impact evaluation.
• Manage and resolve quality-related issues in E&M/Distribution in a timely and effective manner.
• Quality Systems and Continuous Improvement:
• Establish and monitor key performance indicators (KPIs) for E&M/Distribution quality assurance activities.
• Identify and drive continuous improvement initiatives to enhance quality and operational efficiency in E&M/Distribution production.
• Promote a culture of quality throughout the E&M/Distribution organization.
• Evaluate and recommend new technologies, tools, and methods to enhance E&M/Distribution quality assurance processes.
• Team Leadership and Development:
• Lead and manage the E&M/Distribution quality assurance team, including hiring, training, coaching, and performance evaluation.
• Ensure the team is properly qualified and trained on current GMP requirements and quality standards.
• Regulatory Compliance and Inspections:
• Participate in regulatory inspections and audits, providing expertise on E&M/Distribution quality assurance.
• Ensure the site maintains valid manufacturing licenses and product permissions for E&M/Distribution.

About You

Education and Experience

• Minimum Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related field; advanced degree preferred.
• Minimum of 8 years of experience in quality roles; pharmaceutical industry preferred
• Preferred experience/ in-depth knowledge of GMP regulations and guidelines.
• Prefer candidate with previous management experience

Skills & Qualifications

• Strong understanding of pharmaceutical manufacturing processes and associated quality control methods.
• Excellent analytical and problem-solving skills, with the ability to make data-driven decisions.
• Proven leadership experience in leading and coaching teams, fostering growth and innovation.
• Effective communicator with strong interpersonal skills.
• Interacts effectively with stakeholders, including cross-functional teams and manufacturing operations.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.

This position is for a new vacant role that is now open for applications.

AI Usage

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,  Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.

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.

#GD-SP

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.</a