Supply Quality Assurance Manager
What you need to know
You will work a Supply Quality Assurance Manager for our client, a leading Animal health company in Dublin 18. This company is a world leader in the discovery and delivery of quality veterinary vaccines, medicines and diagnostic products, complemented by bio-devices, genetic tests and precision livestock farming.
The mission of the External Supply Quality Assurance (ESQA) team is to ensure the quality of animal health products through management of outsourced activities and oversight of third party contract manufacturers, thereby ensuring the reliable supply of quality products to our patients and their caregivers. Each ESQA Manager has the responsibility for the oversight of multiple EuAfME based contract manufacturing organizations, ensuring global GMP Quality and Regulatory Compliance standards are maintained and the expectations as Marketing Authorization Holder or Distributor are met.
This is a highly independent position operating with minimal supervision requiring a range of GMP experience and technical knowledge, interacting with high levels of management at contract manufacturers. The ESQA Manager will also be expected to interact with other business, supply and manufacturing units and may be involved in cross-functional teams. Each ESQA Manager is expected to be customer and business focused and willing to travel up to 20%.
This is a contract role
Your new job
Key duties & responsibilities:
- Contractor Management: Own and manage the contractor relationship for Quality and Regulatory compliance to ensure contractors have applicable quality systems comply with GMP/regulatory requirements and expectations for marketed products.
- Routine oversight responsibility for Quality Agreements, Change Control, Deviation Management, Market Actions, Lot Approval, Complaint Handling, Annual Product Review, Stability Studies, Validation Approval and Global Compliance Audit Support.
- New Product Introduction: Support business development opportunities in selection, due diligence audit and evaluation of potential contractors in the process of New Product Introduction by supplying appropriate quality input.
- Product Transfers: Act as Quality subject matter expert for product transfer teams, advising on company and GMP expectation regarding process validation and analytical method transfers performed at the contractor.
- Regulatory Compliance: Support and/or conduct Regulatory compliance assessments at contractors. Facilitate the process of documentation retrieval and collation to support Marketing Authorization renewals and variations. Act as QA focal point for regulatory communications and changes.
- ESQA Quality Systems: Contribute to the maintenance and development of the ESQA and company Quality Governance models.
What are we looking for?
- Bachelor/Master degree in Engineering, Pharmaceutical Science, Microbiology, Chemistry or equivalent.
- Certified QP is preferred.
- Minimum 10 years’ experience in Pharmaceutical industry supporting manufacturing operations,
- Fluent in English (written and spoken) and ideally knowledge of one or more European or EuAfME languages.
- Demonstrate knowledge of a range of products and regulatory requirements in the diverse portfolio of medicinal products (ideally including Animal Health).
- Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
- Prepared to take initiative with an ability to handle and prioritize issues accordingly as they arise
- Ability to prioritize workload to act and work independently, a confident decision maker with the ability to recognize significant issues requiring immediate escalation.
- Diplomatic in communication with internal and external stakeholders, strong negotiating skills and a demonstrated ability to resolve conflict to the benefit of all parties.
Apply for this job now or get in touch with Aoife on 090 64 90485.
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