The mission of the External Supply Quality Assurance (ESQA) team is to ensure the quality of Zoetis’ 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 of Zoetis as Marketing Authorization Holder or Distributor are met.
This is a relatively 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 Zoetis 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%.
Role 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 Zoetis expectations for marketed products. Routine oversight includes 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 Zoetis 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 Zoetis’ 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 Zoetis Quality Governance models.
Candidate Requirements
Education & Experience
Bachelor/Master degree in Engineering, Pharmaceutical Science, Microbiology, Chemistry or equivalent.
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, fluency in Turkish (written and spoken) will be considered a distinct advantage.
Technical Skills
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 initiatives 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.
About Zoetis
At Zoetis we are passionate about our customers and the animals in their care. We discover, develop and manufacture the world’s most innovative and effective products for animal health-medicines, vaccines, diagnostics, genetic tests, biodevices-and we are creating the next generation of integrated solutions and services to support this evolving industry. We know our people drive our success. Our colleagues are proud of our company culture and the meaningful role we play in caring for animals. The Zoetis Core Beliefs define the commitments we make to our colleagues, customers and stakeholders every day. They have guided the creation of our award-winning workplace and our proud position as a leading partner of choice in animal health.
Diversity, Equity & Inclusion
Our Colleagues Make the Difference, and we know their differences make Zoetis stronger. We strive to create an environment where each colleague feels valued and cared for and where we can be our best every day. Our Diversity, Equity & Inclusion (DE&I) focus and commitment begins with our leadership team of diverse backgrounds, experiences and ethnicities (50% of our executive team members are women), and it is demonstrated in our support of our colleagues and industry. Our Diversity, Equity & Inclusion Council, representing colleagues across locations, functions and communities, serve as ambassadors and champions for DE&I initiatives. In addition to the Diversity, Equity & Inclusion Council, Zoetis has six colleague resource groups that bring together colleagues who share similar backgrounds, experiences, or interests and work together toward goals aligned with our strategic business priorities.
Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a Best Place to Work for LGBTQ Equality , a 100 Best Company for Working Mothers , a Top Company for Executive Women , among many others .
For animals. For health. For you.
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