External Manufacturing & Supply Operational Quality Manager, Management of CMO

This position is a person-in-plant that is created to support PCV21 project at SK bio in Andong

Department Description:

Gen Med Large Molecules & Vaccines Quality is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products.
Gen Med LM & Vaccines Q staff interact with functional units within Gen Med LM & Vaccines Quality, Specialty Care Quality (SCQ), Sanofi sites, and other organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

• Gen Med LM & Vaccines Q has responsibility for CMO and CLO activities related to products treating Rare Diseases Oncology and Immunology and vaccines

• Gen Med LM & Vaccines Q has offices based in the Netherlands , in Germany, in US, in Spain and in France.

• Gen Med LM & Vaccines Q 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 15+ years of experience working in a cGxP or other regulated environment, with 5+ 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.

• Languages skilss : Korean (native speaker) / English fluent

Special Working Conditions:

• Person in Plant in Angong is required at least 3 days a week.

• For Clinical batches and PPQ : CPV (follow up and reports);

  PPQ follow up and reports

  CPV protocol, follow up and report

• G2+ (new building): Review of the main C&Q documents / Strategies and review/approval/follow up of the Performance Qualification non Product Dependant /Product Dependant

• Inspection readiness: Follow up of the assessments made by the consultants (Nov 23) + CAPA

  Overall inspection plan to be co-built with SK

  PMG process follow up (Initial Technical Assessment, CAPA, support for Mock and Inspection)

  Support for Sanofi audits

• Overall project: QTA update, Quality doc / reports review (in Korean).