OQ Manager (Operational Quality)

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at GSK Irvine Manufacturing Site. The Quality function at GSK plays a critical role in ensuring our products meet the highest standards of safety, efficacy, and compliance. As part of this team you will uphold our commitment to delivering high-quality medicines and vaccines, and healthcare products to patients and consumers around the world.

As Operational Quality (OQ) Manager you will manage Operational quality assurance activities across the site. You will coach and manage a team of Operational Quality Advisors and Quality oversight specialists to ensure products are manufactured and released to GSK and regulatory standards. You will partner with manufacturing, engineering and site leadership to keep processes and equipment within regulatory expectations. We seek a practical, curious manager who improves systems, develops people and helps the site deliver safe, high-quality product.

Direct Reports: As team-manager you will have approximately 10 direct reports.

Responsibilities:

• Leading and developing the Operational Quality Assurance team (including succession planning and coaching).
• Overseeing material release process to ensure effective and compliant review of batch documentation, Laboratory results and all other documentation associated with certification and/or release of materials.
• Ensuring quality investigations and incidents are managed appropriately and effectively.
• Managing periodic reviews (including Periodic Product Reviews – PPRs), and tracking schedules and trends.
• Acting as primary interface between Quality and site functions (to support investigations, CAPAs and change control).
• Providing quality oversight during operations, partnering with Quality oversight specialists to maintain compliant release and quiet hour activities.
• Driving continuous improvement to reduce defects and waste, supporting a culture focused on compliance and patient safety.

About You:

As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has strong experience of working in operational quality role at a complex highly-regulated manufacturing site. You should have people-management experience. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

Basic Qualification:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Degree in a relevant scientific, technical or engineering discipline, or equivalent experience.
• Experience in pharmaceutical manufacturing quality, including operational QA.
• Solid working knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for manufacturing sites.
• Practical experience with process, equipment and/or computer system validation.
• Demonstrable people leadership experience, including coaching and team development.
• Strong communication and stakeholder management skills.

Preferred Qualification:

If you have the following characteristics, it would be a plus:

• A fully qualified QP (Qualified Person).

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive.

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