- Establishment of Beam's Global Validation Program for PPQ/CPV based on current industry practice and guidance from multiple regulatory agencies.
- Leadership and ultimate responsibility for the validation program, including policies, SOPs, plan(s).
- Lead program specific PPQ/Process Validation campaigns including preparation of validation master plans, risk assessments, protocols, and reports. Provide oversight of PPQ and Process Validation execution.
- Develop and facilitate PPQ readiness stage gate process with the cross-functional team to identify, manage and control risks as process progress to and through PPQ execution
- Facilitate Beam's Governance Panel on PPQ Establishment, providing status updates on PPQ/CPV readiness, execution, activities, and deliverables.
- Lead the development of a Continuous Process Verification program, including establishing trending, and annual reporting systems.
- Knowledge management which comprises the available analytical/product/process information into a robust process development history library
- Support Regulatory CMC team to assemble and author portions of BLA / MAA.
- Support Operational Readiness team to ensure validation strategies and planned operational strategies are aligned and commercially supported
- Work closely with Regulatory and Quality teams to defend validation strategies in audits/inspections.
- Mentor teams on the development of a risk-based process characterization campaign that maximizes value for studies results in data to support a PPQ-ready process control strategy.
- Ensures continuous improvement across the aspects of validation.
- Bachelors or Advanced degree in a scientific discipline
- 17+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
- 5+ years of Validation management experience including process validation and/or aseptic process validation.
- Direct experience with multiple successful PPQ campaigns in Biologics and/or Advanced Therapeutics Manufacturing Technologies
- Excellent communication skills, detail-oriented personality, and ability to work across cross-functionally.
- Solid knowledge of global regulations and standards; experience interacting with regulatory health authorities at pre- and post-approval inspection
- Experience leading one or more PPQ/Process Validation campaigns including preparation and execution, validation master plans, risk assessments, protocols and reports.
- Knowledge of US and international regulatory standards and ICH guidelines and substantial experience authoring and/or contributing to regulatory submissions.
- Significant regulatory inspection experience as an SME, or contributor, with emphasis on Pre-Approval Inspections.
- Excellent written and verbal communication skills with the ability to communicate effectively across several disciplines and experience levels.
- Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
- Proven track record of leading cross-functional collaborations to improve business processes.
- Experience leading a Continuous Process Verification Campaign including trending, and annual product life cycle monitoring and reporting with biologic or gene therapy products.
- Prior CMC experience with pre-approval and post-approval activities for a biologic or gene therapy product.
- Excellent team building, leadership and management skills.
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Vice President, Global Process Performance Qualification and Validation - Durham, United States - Beam Therapeutics Inc.
Description
Position Overview:The Vice President, Global Process Performance Qualification and Validation will be responsible for the overall establishment of Beam's Global Validation Program for Process Performance Qualification (PPQ) / Continuous Process Verification (CPV), creation of program specific validation strategies and management of the overall validation program. This is a business-critical position enabling PPQ/CPV readiness, execution and deliverables required for a successful Biologics Licensing Application (BLA) and/or Market Authorization Application (MAA). Beam has prioritized our portfolio to focus on our rapidly growing hematology and liver genetic disease franchises, led by the sickle cell disease and alpha-1 antitrypsin deficiency (AATD) programs, each of which feature potentially highly differentiated programs for large and underserved patient populations. This position can be located in RTP, NC or Cambridge, MA and will require business travel of 15-20%, with some flexible work scheduling available.
Globally, the position will lead the design and implementation of the Validation program at Beam for accelerated/late stage clinical candidates; scope includes validation strategies for manufacturing process, analytical testing, equipment, supply chain, and facility. Serve as Validation project lead and primary point of contact for functional area leads, program teams, and the Executive Leadership Team.
The VP will provide leadership to the validation department, which is responsible for all standards, procedures and requirements for the Validation program, covering all aspects of validation, including facilities, utilities, equipment, instrumentation and computerized systems as well as partnering with technical leaders for creation of environmental monitoring performance qualification, cleaning validation, shipping validation and process validation programs as we progress in product lifecycle. The position will report into the Reporting into the Chief Manufacturing Officer / Head of Technical Operations.
Primary Responsibilities:
