Operational Quality (OQ) Manager - Circa 15-month Secondment / Fixed Term Contract (FTC)

GSK; Eggleston; On-site; GBP 90,000 - 120,000; Full time

Job summary

GSK Barnard Castle seeks an Operational Quality Manager to lead a team ensuring GMP compliance across production, warehouse, utilities and labs. You will drive proactive quality culture, oversee quality decisions, and manage risk-based oversight at a key site.

Reporting to the Operational Quality Lead, you will coach staff, maintain inspection readiness, and partner with area management to optimise quality processes while managing a ~15-month secondment/FTC.

Qualifications

• Degree in relevant Scientific, Technical or Engineering discipline (or equivalent experience).
• Relevant Operational Quality (OQ) experience.
• Team management experience.
• Knowledge of current Good Manufacturing Practice (cGMP).
• Knowledge and application of Quality Management Systems (QMS).

Responsibilities

• Management of a team responsible for GMP processes and adherence to procedures, minimising non-compliance risk.
• Perform spot-checks of activities across GMP areas to ensure quality standards are met.
• Review trends from Quality Oversight to ensure timely actions and changes.
• Partner with area management to support Quality Oversight by owners.
• Maintain Quality Oversight risk assessments based on trends and changes.
• Ensure compliance with the Quality Oversight schedule frequency.
• Ensure facilities are maintained per housekeeping standards and escalate deviations.
• Role model GPS standards and participate in accountability meetings.
• Foster QSWM culture by coaching on procedures and impact of non-compliance.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Degree in relevant Scientific, Technical or Engineering discipline

Job description

Reporting into the site's Operational Quality Lead, The Operational Quality Manager manages a team with responsibility for ensures (across the Barnard Castle site) adherence to GMP standards and procedures through independent oversight of processes via Quality Oversight. The wider remit of the role is to improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging a proactive quality culture (including continuous improvement). The role maintains presence and is accountable for key quality-related decision-making and/or quality escalations, as well as ensuring the frequency and detail of quality oversight process reflects the risk and potential impact of the different processes being overseen. Direct Reports - As team-manager you will have approximately 4 direct reports.

Responsibilities

• Management of a team responsible for ensuring GMP processes and operational personnel adhere to local or area specific procedures, minimising risk of non-compliance and always maintaining inspection readiness.
• Perform spot-checks of activities across GMP areas (including but not limited to production, Warehouse, Utilities and laboratory areas) to ensure compliance with quality standards.
• Review trends from the Quality Oversight process to ensure timely completion of identified actions and implementation of changes to oversight frequency or methods.
• Partnering with area management to ensure Quality Oversight process is supported by departments owners.
• Keep the Quality Oversight risk assessment current based on identified trends and process changes.
• Ensure adherence to frequency of oversight mandated in the Quality oversight schedule.
• Check that facilities are being maintained in line with local housekeeping standards and any deviation from the standards are escalated with associated actions addressed (within a timely manner).
• Role model the GPS standards, participating through tiered accountability meetings (for example, production change over meetings).
• Foster the Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the impact non-compliance can have on product quality and patient safety.

Shift Pattern

Shift Pattern: This role operates on a 24/7 shift pattern (4 days on & 4 days off). The shift includes night and weekend work.

This secondment / Fixed Term Contract (FTC) is expected to last circa 15-months in duration. Please ensure you have spoken with your line-manager to ensure they are supportive of your application (this includes a timely-release from your current responsibilities should you be offered the Secondment).

Requirements

• Degree in relevant Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly-regulated industry).
• Relevant Operational Quality (OQ) experience.
• Team management experience.
• Knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Knowledge and application of Quality Management Systems (QMS).

What we value

We welcome people who bring curiosity, humility and a practical approach. We are committed to inclusion and to creating a supportive environment where everyone can grow. If you enjoy solving real problems, delivering measurable results, and helping teams succeed, we encourage you to apply.

Key Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

About the Quality Function

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at GSK Barnard Castle 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.

GSK Barnard Castle is a key secondary manufacturing site. We have invested heavily in industry 4.0 state of the art bespoke equipment to support sustained new product introductions and volume increases. As a key supplier of some of GSK's blockbuster products the site contributes revenues of ~$2Bn annually.

Unite 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.

Equal Opportunity Employer

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.

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