Associate Director, Commercial Quality Assurance
hace 7 meses
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
**Company Overview**:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
**Position Overview**:
The Associate Director, European Commercial Quality Assurance is an integral position leading regionally based sponsor quality oversight of aseptically produced contract manufactured PET drug radiopharmaceuticals.
The position works alongside management, R&D Quality, Global Investigational Products and Commercial Quality Assurance, and CMC functional teams to establish quality assurance contracts, support tech transfer, (re)qualify contracted partners, approve manufacturing documents, oversee, and report key performance indicators, GMP exceptions and changes. This role establishes and maintains standard operating procedures in alignment with corporate quality standards and current GMP expectations. In collaboration with QA management, this position identifies annual Commercial QA objectives, strategies, and solutions to achieve these responsibilities, improve the local quality system, identify workstream efficiencies, and manage annual budgets.
**Responsibilities**:
- Leads efforts to create, revise, and ensure the functional area quality system remains current to corporate quality standards, regulatory expectations, and sponsor quality oversight objectives.
- Creates, revises, and assures a proper risk-based sponsor quality oversight strategy of CMOs via Quality Agreements, performance and trend monitoring, and routine quality oversight, including sponsor batch release, as required.
- Plans, leads, executes, supports CMO GMP and process qualification
- In collaboration with joint teams and Quality leadership, leads/supports the planning, evaluation, and presentation of GMP performance, risks, trends, and assures risk-based improvements by CMOs and the drug sponsor
- Leads or supports efforts to continually strive to reduce risks in contract manufacturing and efficiencies in workstreams
- Provides QA support to sustain reliably suppled medicines
- Assures electronic manufacturing solutions are consistent with regulatory filings, the approved validated process, specifications, and established procedures.
- Supports, contributes, and assures the adequacy of annual product reviews/product quality reviews
- Leads sponsor responsibilities related to critical events management and health authority post market reporting, as required.
- Reviews the adequacy of product complaint investigations
- Executes functional area on-going inspection readiness, and supports internal self and regulatory inspections
**Basic Qualifications**:
- Bachelor’s degree in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry and a minimum 5+ years’ experience in pharmaceutical or medical device manufacturing Quality Assurance with at least 3+ years’ relevant to parenteral product aseptic processing
- Strong knowledge of commercial and investigational drug product EU GMP regulations (e.g. Eudralex Vol 4 GMPs, and applicable guidelines)
- Minimum education requirements to fulfill Qualified Person duties
**Additional Skills/Preferences**:
- Very knowledgeable in pharmaceutical GMP aseptic processing, facility design, environmental monitoring controls, workflows, process and equipment validation and qualification
- Experienced aseptic process microbiological contamination control strategies and identifying sources of contamination
- Proficient in the execution and reporting of GMP quality audits of aseptic manufacturing facilities, manufacturing processes, laboratories, environmental monitoring, and controls
- Able to interpret GMP/ICH regulations to develop site level procedures, and assure the adequacy of CMO procedures and risk-based control strategies
- Experienced in contract manufacturing quality oversight and developing risk based appropriate oversight strategies
- Well versed in root cause analysis deviations and OOS investigations, failure m
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