Associate Director, QA Technical Commercial GMP Operations (Hybrid)

Job Description

General Summary:

As an individual contributor and a subject matter expert, the incumbent will have wide range of Quality Technical related responsibilities within Biologics and Combination Device Quality organization. Responsibilities will include but not limited to development and maintenance of quality risk management, be integral part of biologics product investigation, material review board, change control, quality agreement reviews, product recall management, compliant management, and having vendor interactions globally with external Contract Manufacturing, globally (US and ROW). The incumbent is known for technical and product quality expertise and assists with the strategic alignment of program and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement.

Key Duties and Responsibilities:

• Direct multiple teams responsible for external quality commercial operations in support of GMP manufacturing and testing activities, including US and ROW.
• Negotiate, monitor and maintain Quality Agreements with Partners, CMOs, Contract labs, Vendors, where applicable.
• Monitor CMO oversight activities and assesses for continuous improvement, including Annual Product Reviews, Contamination Control, Vendor Risk Management
• Oversee execution of the APRs and elements of the QMR
• Participate in pre-approval inspections and routine regulatory surveillance inspections
• Participate in product recall management
• Participate in product complaint management
• Leads Biologics Quality Risk Management
• Participate in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary
• Provide guidance and support to in-country Quality representation in relevant geographies
• Ensure quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Lead Material Review Board discussions, as necessary.
• Ensure quality staff assess and approve change controls for commercial processes, globally
• Ensure regulatory submissions align with filing strategy; review and approve submissions amendments.
• Support development of Quality Metrics to support process improvement activities
• Lead and manage highly complex projects/teams within corporate objectives and project timelines
• Participates in cross-functional projects in Quality expert role
• Provide operational strategies to address compliance gaps or determines enhancements to cross-functional quality systems
• Provide support or assist with hosting or inspection support for partner and regulatory agency audits
• Collaborate with in house Quality counterparts on quality technical investigations
• Provide training and educational training and latest regulatory trends.

Knowledge and Skills:

• Expert knowledge of both the conceptual and practical application of cGMPs in a Biologics setting; expert knowledge of global GMP requirements and managing quality in support GMP manufacturing
• Highly effective management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
• Expertly lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
• Substantial skills in transferring technical knowledge to enable their capabilities and development
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action; negotiation skills may required
• Demonstrated ability to evaluate unusually complex quality or multi-disciplinary matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
• Extensive experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Extensive experience in biologics product complaint management, recall management, biologics change control, analytical method validation, and quality risk management.
• Extensive knowledge on creating and reporting quality metrics.
• Extensive knowledge in cGMP Drug Substance Manufacturing and regulatory standards
• Extensive exposure with multiple regulatory agencies across