QC Manager Analytical Excellence, Meriden, Connecticut

Job description

Mission

To help lead the Quality Control Transversal Projects to achieve analytical excellence in quality control testing in cGMP environment. Major responsibilities include stability program management, transversal projects management, trending of quality control metrics, responsible for pharmacopeia site contact, maintaining a high level of regulatory and safety compliance, and providing technical/scientific guidance on test issues and interpretations.

Key accountabilities

(4 to 6 key accountabilities):

35% Testing/Process Activities – Transversal project management. Demonstrate scientific and technical expertise in various analytical assays used in quality control. Exhibit proficiency in troubleshooting issues work within and across teams to support internal/ external departmental projects. Support manufacturing investigations. Participate in review and peer proofing activities within and between departments. Management of stability program

35% Quality Systems / Compliance - Identify opportunities for quality improvements through trending of quality control metrics. Interact with Quality Assurance to ensure closure of compliance gaps. Lead incident/OOS investigations ensuring that the investigation is thorough and completed in a timely manner. Represent the department during transversal projects. Write and revise documents as required to ensure regulatory compliance, conciseness and consistency. Site contact for the Pharmacopeia activities.

15% - Documents/Procedures - Facilitate revision of documents as necessary to ensure regulatory compliance and ease of use. Review/approve documents as necessary. Consolidate documentation where applicable to improve testing efficiency and reduce the risk of procedural deviations. Projects - Identify opportunities in the areas of cost reduction, increased productivity and regulatory compliance.

15% - Training - Train others on the theory and technical components of the processes, procedures, assays, and equipment within areas of expertise. Serve to enhance team communication and cohesiveness through coaching and mentoring peers.

Scope and dimensions

Breadth of responsibility (global/regional/country/site): Protein Sciences (Meriden) Site

Key dimensions : headcount (direct and indirect) budget, doses, Capex… - Key indicators on which the job holder will be evaluated (WHAT in 9box): Core Competencies

Act for Change, Cooperate Transversally, Strive for Results, Commit to Customers, Strategic Thinking, Develop People, Lead Teams, Make Decisions

Freedom to act, level of autonomy : Within scope of position.

Education and experience

Specific degree, duration of experience (Required to hold the job):

Advanced degree in a scientific discipline with 10 years experience in a cGMP laboratory setting. In addition, the candidate should have a minimum of 3 years experience in management of laboratory operations. Knowledge of international regulations for cGMP laboratory settings. Experience in management of stability program including stability analysis.

Competencies (LEAD model) – key competencies the job holder will be evaluated on (HOW in 9box):

Will be evaluated on the companies key competencies.

Key technical competencies and soft skills :

2+ years of experience in management of transversal projects in cGMP Laboratory settings. International experience for transversal projects is a plus.

1 plus years experience in preparation of budgets, planning costs and expenditures

A general understanding of resource allocation and the development of a matrix environment

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.

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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.