Manager, Quality Assurance, Batch release

Job Description

A fantastic opportunity has arisen for a Quality Assurance Manager (Batch Release) at our Carlow site.
This is our state-of-the-art filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product.
This position provides a unique and outstanding opportunity to develop our QA team and shape our business strategy for the future.

Key responsibilities will include: 

• Manage, lead and mentor the QA Batch Release team to ensure objectives are effectively achieved, consistent with our Company 's requirements to ensure compliance, safety, and reliable supply to our customers.

• Work as directed by the Associate Director of Quality Assurance according to Company safety policies, cGMP and cGLP. Drive compliance with our Company Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.

• Develop and maintain effective cross-functional relationships with IPT leads and support functions. Use MPS/Lean principles to ensure quality systems and work practices are effective, efficient and ensure compliance.

• Leadership of the QA Batch Release team including selection, development, coaching and day to day management.

Provide mentoring and guidance to the IPT and support functions to ensure manufacturing and release activities are performed in compliance with applicable procedures, our Company Global Policies and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).

• Provide compliance and technical leadership to IPT and support functions in resolution of investigations. Provide support with audit/inspection requirements to ensure department compliance/readiness.

• Participate in internal and external audits and inspections, taking the role of auditee for assigned.

• areas of responsibility.

• Use MPS tools and methodology to drive continuous improvement of practices and procedures ensuring compliance in an effective and efficient manner.

• Top of Form

Your profile:

• Bachelor’s Degree or higher preferred in a Science related discipline. 3-5 years’ experience in a quality role, ideally in a pharmaceutical manufacturing environment.

• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Knowledge of cGMP and Quality Systems as they relate to sterile filling operations.

• Understanding of Lean Six Sigma Methodology preferred.

• Excellent communication, presentation, and people skills, to interface effectively with all levels of colleagues and with external customers in a collaborative manner.

• Understand the specific responsibilities of all Carlow functions as they relate to one’s own department and understand the business processes one’s department supports.

• Progressive people management skills.

• Risk management & strategy development skills.

• Demonstrable analytical and systematic problem-solving skills.

• Strong change management skills.

• Ability to effectively manage complex projects across multiple disciplines.

• Excellent facilitation and assessment skills, proven financial management skills and the demonstrable ability to work independently.

• Focus on Customers and Patients and cross functional collaboration.

• The ability to make rapid, disciplined decisions.

• Drive Results. Build Talent. Demonstrate Ethics and Integrity

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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Relocation:

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