Quality Assurance Lead

Why Patients Need You 

At Pfizer, everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Through your expertise and extensive knowledge, you will be able to foster a culture that promotes quality and compliance and thrives on doing better for patients and healthcare - your contributions will directly impact patients.   

Situated in Co. Kildare, Pfizer Newbridge is an integral part of the global solid oral dose network; manufacturing tablets and capsules for world markets using leading edge and highly complex manufacturing and analytical processes.

The Newbridge site has been an established leader in the supply of medicines for over thirty years and is currently expanding its product portfolio. The Quality team is seeking an experienced Quality Assurance Lead (Senior Manager) to support this additional activity on-site.

The successful candidate will manage all Quality Assurance Activities associated with a Business Unit for a defined suite of Products, also fulfilling an influencing role within the both Quality and extended site Leadership Teams. This is an exciting career opportunity to operate in a dynamic team environment, meeting business objectives through effective direction (coach, mentor and lead) - developing and supporting high performing teams in delivering solutions.

Expectations / Responsibilities of the Role

• Contributes as a QA leader as part of a cross functional team, and as member of the QO leadership team.
• Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards and business needs
• Decision making authority with respect to product quality, safety and efficacy in consultation with relevant stakeholders
• Quality oversight on Change Controls and Investigations (manufacturing, complaints, laboratory).
• Management and oversight of Product Stability performance.
• Annual Product Record Review approvals.
• Quality oversight for Validation (process, equipment, computer systems).
• Quality oversight for raw materials, packaging components, in-process product and supplier qualification.
• QA support for the introduction of new, innovative products
• Providing QA technical direction and guidance to achieve overall business objectives.
• Ensuring the QA function delivers efficient and effective business processes to support lean operations.
• People reporting responsibilities, which includes selection and recruitment of colleagues. The role will support a QA team of ca. 10-15 people.
• Responsible for area budget preparation and management in conjunction with the Quality Operations Lead

Applicants will have:

• Third level Qualification Degree or higher in Science or a related discipline
• Experience in both QA and QC is desirable
• Eligibility for Qualified Person status (desirable)
• Experience in a Pharmaceutical Management position.
• Ability to interact in a corporate environment, with proven leadership qualities.
• Ability to represent the company in external forums, https://e.g., in interaction with regulatory agencies.

 
Work Location Assignment: On Premise

  
Work Location Assignment: On Premise

Additional Information 

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland. 

• Please note there is no relocation support available for this position 

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How to apply 

• Make a difference today, all suitable candidates should apply with CV below.  We are looking forward to hearing from you! 

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Purpose  

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. 

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. 

Quality Assurance and Control#LI-PFE