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Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Senior Manager, Quality Assurance (External Manufacturing)


Reference:KS/ABHK-407530 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a Global Biopharma with extensive Manufacturing & Global operations in Cork. They are seeking a Senior Manager, Quality Assurance for their Cork operations. The person shall have a strong QA Biopharma/Pharma background. External Manufacturing experience & CMO experience is a distinct advantage. Managing CMO’s mainly based out of Europe but, there may be a need to support outside of Europe if needed. This role will not have any direct reports, it will be an individual contributor role. Injectables & drug product experience a distinct advantage.

Role/Responsibilities

  • Ensures quality oversight of commercial and/or development products at CMOs
  • Oversees the commercial and/or development implementation of the Quality strategy for our clients development portfolio of products and/or across quality sub-functions
  • Partners with Development, Manufacturing, Supply Chain, Outsourcing and Drug Substance to deliver on development programs
  • Ensures that performance and quality of drug products conform to established standards and regulatory agency requirements.
  • Assure CMO’s meet our clients quality, regulatory and compliance standards, in order to ensure a sustainable delivery of quality product to patients and maintain a good working relationship
  • Reviews regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections
  • Collaborates, engages and works cross-functionally with other Quality groups
  • Acts as an escalation contact for complex and high impact quality issues, concerns and decisions.
  • Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)
  • Quality Risk Management, identifying key risks impacting commercial and development programs
  • Competent in execution and responsible for translating quality strategy into plans of action.
  • Anticipates shifts in industry trends and regulatory environment that will impact our clients business needs and positions the function to respond accordingly.
  • Participates in developing controlled documents (e.g. SOP’s, validation, etc.)
Knowledge & Skills:
  • Demonstrates understanding and application of GMP principles, concepts, best practices and standards in the US and internationally.
  • Ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
  • Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.
  • Ability to provide guidance to solving problems, uses our clients Quality standards, regulations and industry practices.
  • Demonstrates extensive knowledge of industry best practices and trends.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Is comfortable interacting with regulatory agencies as needed.
  • Demonstrates the ability to manage staff.
  • Participates in compliance audit as required
Education/Experience:
  • Significant years of relevant experience and a Bachelor’s degree in science or related fields or advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
  • Prior people management experience is beneficial.
  • Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
  • Biopharmaceutical and/or Pharmaceutical experience preferred.
  • Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance, understanding of Parenteral and Aseptic processing. OSD and Biopharmaceutical operations is beneficial.

For further details please contact Karen Shiel on 087 7452487 or send CV to [email protected]