Sanofi Group PI Manager in Swiftwater, Pennsylvania
The PI Manager, in the FFIP organization manages people and process responsible for the aseptic fill operations carried out at the Swiftwater Site.
Deviation System point of contact for FFIP, primarily within the Filling and Inspection areas.
Leads a team composed of a combination of Technicians, Professional Production Support and Managers Production Support that is responsible for timely closure of lot related and other deviations and thus has significant regulatory impact in supporting FFIP in keeping in a compliant and audit ready state.
Facilitates cross-functional interfacing activities with stakeholders in a very positive manner: Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance.
Responsible for management and coaching of direct reports, facilitate deviation investigation process and assist in identifying appropriate corrective and preventive actions.
Reviews deviations for completeness prior Director review
Leads complex investigations using advance RCA tools (6Ms, Cause-Effect, Is-Is Not, 5Whys, kaizens, etc).
Well versed in multiple type of investigations including HE, EM, Equipment, Customer Complaints.
Responsible for delegation of department or functional area deviations to the appropriate PI’s, and ensuring they are assessed and investigated in a timely manner, compliant with our SOP.
Facilitates resolution to unresolved issues and deliverables by leading meetings, positively influencing functional manager, removing obstacles and managing projects and priorities, which are critical to ensuring critical lot release.
Promotes professional development of self and direct reports by identifying opportunities in investigation methods, quality engineering, technical writing and applicable sciences that help equip the team to complete the mission.
Develops and analyzes weekly status and trending reports and monitors and reports progress to FFIP and QA Compliance Management, and Planning in a most timely manner.
Assures that operations are safe and in compliance with Quality Systems, cGMP, CBER, WHO, EP and other regulatory bodies.
Required to possess and demonstrate excellent interpersonal/communication skills and management by influence skills, flexibility and the ability to lead and participate on teams.
Conducts performance reviews for direct reports within the department.Knowledge and Skills:
Deep understanding of cGMPs and manufacturing activities including: aseptic filling, lyophilization and visual inspection.
Knowledgeable in lean manufacturing concepts and principles.
Experience conducting root cause investigation and knowledgeable in the use of investigation tools like: brainstorming, cause and effect diagrams, 6Ms, Is/Is Not and others.
Excellent technical writing skills as applied to the generation of investigation reports.
Good project management and organizational skills.
Proficient in Microsoft Office (Excel, Word and PowerPoint)
Strong time management and prioritization skills
Knowledgeable in ERP system (SAP preferred)
Quality Management Systems (TrackWise)
Root Cause Investigation Principles
Six Sigma and Lean Manufacturing
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit:www.sanofipasteur.comorwww.sanofipasteur.us
Sanofi Pasteur SAand 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.
Bachelor level degree in Life Sciences or Business Administration with experience working within a production department of a pharmaceutical or Biotech Company.
3 - 5 years of experience in manufacturing and or development departments.
Working knowledge of cGMP's.
Candidate must be able to work overtime and flexible hours, including weekends.
Primary Location: United States-Pennsylvania-Swiftwater
Job Posting: Sep 15, 2016, 7:24:38 AM
Job Type: Regular
Employee Status: Regular