Direct Hire – Assoc. Dir, External Quality, Biologics & Parenterals (19-00651) – NC – Raleigh

Job Summary:
The Associate Director, EQO is responsible for leading a department the External Quality Operations (EQO) group, primarily focused on biologics and parenterals. The group has quality oversight of active pharmaceutical ingredients (APIs) and Bulk Drug Substances (BDS) and finished drug products (FDPs) manufactured by external manufacturing organizations (EMOs) for commercial and clinical distribution.

He/she is responsible for ensuring consistent and rational application of quality policies amongst the external product teams. He/she is highly independent given his/her extensive GMP, scientific and technical knowledge, and job-related experience and leads a group managed in a matrix environment. He/she ensures effective teamwork by developing strong relationships with direct reports, internal/external customers, peers, and management, and through highly effective (oral and written) communication skills. He/she reports directly to Senior Director, Americas Region Quality.

Responsible for developing, recommending and managing quality project plans, vendor quotes, timelines and budgets for project. May manage CMO capital projects depending on the nature of the investment.

The Associate Director, EQO is directly responsible and accountable for ensuring that the following key activities are executed according to the agreed schedule(s) for all external products:
• Quality responsibility for externally manufactured products (domestic and international)
• Managing EQO resources (budget, personnel and systems)
• Developing EQO personnel
• Developing and improving EQO processes to enhance efficiencies and compliance
• Managing (i.e. review/tracking/assessing impact) EMO compliance of quality
• Establishing and managing metrics for EMO quality, as well as indicators for EQO performance efficiencies
• Evaluating and managing potential quality impact of product complaints as reported and as a result of trends
• Evaluating and managing regulatory compliance of EMOs and assessing due diligence of candidate EMOs in conjunction with Global Regulatory Affairs (GRA) and other functions
• Executing product disposition, as needed
• Managing/reviewing –
Quality Agreements with EMOs
Product data trends in conjunction with Technical Operations, as well as evaluating and communicating impact to product
 Comprehensive reports (i.e. stability reports, relevant CMC international regulatory filings, and Product Quality Reviews), and electronic files (i.e. all batch and product information)
He/she is also expected to continuously assess internal Quality systems for their applicability in managing EMO compliance.
He/she must expect to travel approximately 10% of time (domestic and international).

Essential Functions
1. Manage and develop EQO personnel
2. Leading a group working in a matrix managed environment and communicating (oral and written) with EMOs, product team members, and management to ensure compliance commitments and other assigned work are accomplished on time for external products
3. Managing (i.e. evaluating/resolving) compliance of EMO’s quality systems and adherence to Quality Agreements – especially for change control, deviations/investigations, and OOS
4. Trending and evaluating data for impact to product on continual basis; including in-process, release, and stability data, and product complaints – for multiple products
5. Preparing and managing all reports required for international regulatory submission and maintaining regulatory compliance; and managing e-files for these reports, as well as product information for multiple products Author CMC sections for regulatory filings (CTD/NDA/BLA or IND)
6. Continually assessing and improving EMO Quality systems for compliance and efficiency
7. Establishing and managing metrics for EMO Quality, as well as indicators for EQO performance and efficiencies
8. Developing and maintaining expertise in scientific, technical, and international regulatory topics. Sharing this information with others in Quality Operations and Client as a subject matter expert (SME) Serve as a EDCS Quality Assurance contact for the transition of BDS and drug products from late-stage development, phase 2/3 to commercialization. The position will work with Development Operations (DO), Global Formulation Research (GR), Demand Innovation (DI), and Development Quality Assurance (DQA) to transition the Quality oversight responsibility from DQA to EDCS Quality. Strategizing efficiency of BDS/API/FDP stability program(s), as well as managing these program(s). Coordinates with the Analytical Development group to review/approve the phase appropriate qualification/validation of analytical procedures, the transfer of such procedures into QC or contract test laboratories and the setting of appropriate release specifications

• BS degree in Engineering, Chemistry, Biochemistry, or equivalent technical discipline, advanced degree a plus
• Broad working knowledge of global regulations (i.e. ICH guidances, FDA/EMEA GMP regulations and guidances) for manufacturing, packaging, and distributing active pharmaceutical ingredients and finished drug products
• Broad working knowledge and experience with implementing quality systems
• Broad working experience with evaluating quality systems specific to different manufacturing environments; i.e. aseptic processing
• Critical reasoning skills and demonstrated ability to assess impact of planned and unplanned changes on product quality
• Strong organizational and personnel management skills
• Ability to strategize (i.e. see ‘big picture’) and provide attention-to-detail when needed
• Highly effective oral and written communication skills
• Ability to effectively interact and build relationships at all levels of the organization, as well as with external contractors and strategic business partners
• Ability to represent organization during international regulatory inspections
• Broad working knowledge and experience in drug development, technology transfer, and commercial supply of parenteral and biotechnology products
• SME in aseptic processing and biotechnology products

Minimum of 12 years related experience in pharmaceutical industry
• Demonstrated analytical skills to lead investigations of quality issues, and justify CAPA with appropriate documentation
• Demonstrated ability to broadly assess domestic and international regulatory compliance audit findings and implement CAPA through negotiation
• Experience with assessing Validation requirements for manufacturing processes, facilities, and equipment
• Demonstrated skills to directly or indirectly lead and contribute to product teams in a highly matrixed environment
• Demonstrated initiative to seek and evaluate requirements of product team, as well as other internal and external customers
Minimum of 5 years supervisory/management experience

Desirable But Not Essential
• Advanced degree in Chemistry, Biochemistry, or equivalent technical discipline
• Analytical method transfer and validation
• Broad working knowledge and experience with functions of relevant departments (i.e. R&D, International Regulatory Affairs, Manufacturing) in pharmaceutical industry
• SME in quality attributes for multitude of Production Operations areas, such as Manufacturing, Packaging, and Warehouse and distribution logistics
• Working experience with Project Management tools – such as Kepner-Tregoe problem-solving and decision-making in Project Management
Working knowledge of automated or enterprise quality systems and resource planning
Serve as an SME for areas of responsibility during regulatory inspections
Source: Job Diva – Job Listing

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