Purpose

The Product Quality Manager is responsible for providing quality assurance support for biologics manufacturing. This role will support areas concerning manufacturing, engineering, operations, logistics, quality control, training, and investigations with a focus on batch release. This position will furthermore support compliance and relevant regulatory requests in responsible manufacturing areas.

Responsibilities

• Ensure proper integration and support of site, global, and health authority quality requirements, bulk drug substances and other application areas.
• Lead a quality team and provide guidance in cross function teams in the preparation, review, approval, and execution of quality documentation.  Develop team training program to grow team skills and knowledge for emerging business models.   
• Involvement in relevant investigations and associated CAPAs with a responsibility of approval and assurance of compliance, including integration with quality risk management.
• Participate in change control discussion and implementation within clinical and commercial programs, partnering with relevant functions to ensure quality minded outputs.
• Support new product, tech transfer, and continued production of clinical and commercial programs.
• Interact with internal and external stakeholders for relevant projects and programs to ensure disposition schedule compliance, or appropriate management elevation.
• Perform assessment to determine compliance to processes and regulations to identify potential gaps, mitigate, and implement improvements within our quality system.
• Perform batch release and hold responsibility for activities associated quality batch disposition.
• Participate in internal, client, and health authority audit as a functional area SME.
• Lead and present in relevant meetings as functional area SME. Partner with functional areas (S&T, Compliance, Quality Control, Engineering, Validation, etc) to ensure compliance and quality minded execution.

• Bachelor’s degree in Biology, Microbiology, Engineering, Chemistry, or other technical scientific area preferred.
• Minimum 8+ years of experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professional and in leading cross-function teams.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological, or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and products.
• Experience working in both a team setting and independently. Works well with manager guidance while able to manage own time.
• Strong verbal and written communication skills at all levels of management.
• Excellent interpersonal skills.
• Ability to lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

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