Quality Lead, External Manufacturing & Supply

• Reporting to Quality Assurance APU Head (USA)

• Organization : Rare Disease, Oncology and Immunology External Site Team

External Manufacturing and Supply (EM&S) Large Molecule Specialty Care organization is accountable for all Contract Manufacturing Organizations (CMOs) across the Specialty Care GBU that delivers Sanofi products. We serve the GBUs within M&S with drug substance, drug products, and finished goods, aiming to develop ourselves into a best-in-class organization 
that continuously strives towards three priorities – (i) Ensure Supply, (ii) Deliver Financially, and (iii) Grow Talent. In addition to Running the Business, we are committed to Transforming the Business by defining our strategic global footprint for preferred partners and deploying the right technology in centralized performance management of CMOs. 

• EM&S LM SC has offices based in Northborough and Cambridge, MA US; Frankfurt, Germany; Ghent and Geel, Belgium and Amsterdam, the Netherlands 

• EM&S LM SC personnel may also be located remote or on-site at CMOs acting as a Person-in - Plant

Position Summary:

The QA Manager is the responsible Quality point of contact for the CMO, providing direct support from a quality and compliance perspective. 

The QA manager coordinates oversight of all quality interactions with the CMO and serves as the quality representative in both internal core team meetings and joint meetings with the CMO. 

The role is responsible to ensure cGMP documents and records obtain and meet expectations for the required Sanofi review and approval in accordance with Sanofi procedures and guidelines.

Core Responsibilities

• Act as CMO Quality site contact and responsible for CMO quality oversight

• Quality representative actively engaged in internal core team meetings and joint meetings with the CMO (s)

• Responsible for quality oversight of cGMP documents and records (includes but not limited to: batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements, produt technical specifications):
  - responsibility includes ensuring applicable documents/records receive the appropriate level of Sanofi Subject Matter Expert review in accordance with requirements of Sanofi procedures and standards
  - responsible to review and approve documents in the QA capacity

• Responsible for product release in accordance with approved specifications and procedures

• Monitor contractor performance to established key performance indicators (KPI) and report and escalate adverse trends

• Ensure adequat remediation plan to improve KPI as well as risk ranking outcome

• Demonstrate understanding of applicable health authority regulations related to manufacture of medicinal products (small molecules and biologics)
  

Department Management

• Establish and report applicable department or organizational metrics.

• Accountable for project completions and achievement of compliance goals.

• Represent department in meetings.

• Interact with project teams ( Tech Transfer) and cross-functional groups.

• Address and/or escalate compliance problems and issues to department/organizational management.

• Lead and facilitate meetings/workshops.
  

Additional Responsibilities

• May be assigned a leadership role (e.g. Site Process Owner) in a Community of Practice, e.g. Change Control, Data Integrity.
  

Basic Qualifications:

• Bachelor’s degree and 10+ years of experience working in a cGxP or other regulated environment, with 3+ years of experience in a Quality role.

• 2 – 5 years supervisory and/or management experience.    
  

Preferred Qualifications:

• Familiarity with global cGMP and ISO regulations relating to medicinal products; Understands principles, concepts, practice and standards for Quality Assurance function and experienced in evaluating and applying compliance guidelines to new and real-life situations

• Experience with data analysis, trending, and presenting material within multi-functional environment.

• Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.

• Excellent communication and negotiation skills.

• They function well in a highly matrixed organization.
  

Special Working Conditions:

• Ability to support Person in Plant at a local CMO is required.