Senior Manager, Quality

Catalent Pharma Solutionare seeking to recruit a Senior Quality Manager to lead our Quality team at our Bathgate facility.

As the Senior Quality Manageryou lead a team responsible for promoting a positive culture of pollution prevention and minimization of the company’s environmental footprint through recycling, reducing energy usage, water usage and waste minimization. You will also ensure the integrity of Clinical and commercial products received stored and packed for shipment at BTH are compliant with cGMP.

The role of Senior Quality Manager will report to the site Quality Director, carry out functions relevant to the Quality (GMP) objectives and policies of Catalent.

The Role

• Develop, maintain and ensure compliance of the Quality Management system and activities where required.

• Ensure professional fully trained Quality support is provided to all appropriate departments to allow timelines and deliverables to be met.

• Identify quality improvements and enable improvements to be implemented in a compliant and controlled manner.

• Guarantee the safety of product and people by working in compliance with the site rules and all EHS procedures.

• Lead and develop a team of Quality Specialists and Quality Administration ensuring the following tasks are executed:

• Review and release of Standard Operating Procedures.

• Review and approve Clinical and commercial Pre and Post Packaging Batch Records to ensure compliance with GMP and company procedures. Keep management informed of issues which could influence company business or compliance

• Review and release Bulk Materials and Finished Goods to ensure compliance with GMP and company procedures. Keep management informed of issues which could influence company business or compliance

• Review and approve Material Specifications to ensure compliance with pharmacopoeia and client requirements.

• Review and approve Randomisations to ensure compliance with GMP and client requirements

• Review and approve Pre and Post Qualification documents for packaging equipment

The Candidate

• Educated to BSC in a level in relevant scientific topic or appropriate experience in Quality Management within a pharmaceutical and /or GMP environment

• 5 years or more experience of Pharmaceutical/Clinical Trials Packaging and / or GMP Processes or equivalent or

• Strong leadership skills to lead a team to meet client and regulatory expectation.

• Demonstrable experience and sound knowledge of GMP regulations

• Ability to interact with personnel at all levels from a variety of disciplines Strong analytical and problem-solving skills

• Good negotiation skills

• Excellent verbal/written communication skills.

• The ability to prioritise daily/weekly workload

Position Benefits

• Annual Salary

• Pension

• Life Assurance

• Bupa Healthcare

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.