Sanofi Group Manager, Quality Validation - Vaccine in Pearl River, New York
Provide support to ensure that all validation initiatives supporting our manufacturing environments are compliant with Regulatory and Global Quality policies and standards. Provide quality support on projects including management of Protein Sciences (PSC), A Sanofi Company, Change Control process. This position also provides support for establishing the site validation master plan and monitoring progress of the plan. As a member of the Quality Operations team, you will support strategic direction for all quality and compliance processes as well as actively participate in the development of strategies for all on-site and global continuous improvement projects.
Support effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments.
Support the team to ensure that Validation Master Plans, qualification and validation protocols and reports are aligned with CFRs and regulatory, global and internal guidelines.
Support through Quality Review performance of Qualification/Validation activities at Pearl River and Meriden Protein Sciences Corporation facilities, including computerized systems and cleaning validation.
Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving validation of the manufacturing process or environment.
Support Pilot Trending analysis (contamination control, trending aseptic performance, correlation EM to sterility assurance, sanitization, sterilization effectiveness).
Manage quality projects across functional areas and act as quality representative for global projects.
Provide Quality support to ensure that the Change control process is managed according to current regulation (external and internal). Support Management of PSC Change Control Committee.
Collaborate with global counterparts to ensure alignment of methodologies and best practices. Communicates and partners with site functions to ensure processes are aligned to program requirements and identify improvement opportunities.
Serve as mentor for less experienced teammates, assisting with technical development.
Context of the Job/Major Challenges:
This position must interact successfully with the fast paced project team and have a good understanding of project management
Strong communication skills are critical to ensure teams are guided through validation strategy and cGMP requirements.
Strong supervisory, and both written and oral communications skills
Strong analytical and balanced decision making skills
Ability to understand role's impact and influencing skills
Diverse business, quality, and industrial manufacturing knowledge base
The job holder will provide quality oversight for validation contractors at both the Pearl River, NY and Meriden, CT facilities. The job holder will be evaluated on Safety, Quality, Delivery and Involvement. The position requires communication with Regulatory Affairs, Production, and communication with R&D as required. As Quality validation Subject Matter Expert, the job holder will also provide quality input in regards to validation activities and changes at CMOs.
Scope of position: This position has no direct reports.
Minimum Bachelor’s Degree required, preferably in a Scientific, Engineering or a similar field
Minimum 8 years' cGMP experience in Validation and Quality/Compliance preferably in a cGMP Pharmaceutical, Biotech or Medical Device industries .
Familiarity with regulatory requirements, experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA)
Experience with face to face presentation of technically complex subjects to regulatory inspectors.
Skills/Competencies Of The Successful Candidate:
A collaborative teamwork style across all functions within and external to the PSC.
Effective interpersonal communication and presentation skills (written and verbal) with proven ability to positively influence behavior and outcomes.
Strong technical problem-solving abilities.
The ability to work well under pressure, achieve results within tight deadlines and function effectively and independently in a fast-paced, dynamic environment.
Preferred Experience and Skills:
MS degree in Engineering, preferred.
Knowledge of regulations for Japan and Canada are nice to have
Experience in bulk upstream and/or downstream vaccine processes within a current Good Manufacturing Practices (cGMP) environment.
Experience with facility, equipment, and process start-up in a sterile current Good Manufacturing Practices (GMP) environment.
Sanitization and Sterilization validation (SIP, autoclaves, Cleaning validation (CIP, COP)
Validation experience in support of Good Manufacturing Practices process demonstration (IQ/OQ/PQ) sustaining the validated state through change management and continuing validation studies.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.