At a Glance
- Tasks: Lead a team to ensure quality and compliance in manufacturing processes.
- Company: Join GSK, a leader in pharmaceutical manufacturing with a commitment to quality.
- Benefits: Competitive salary, career development, and a focus on patient safety.
- Other info: Opportunity for growth in a highly regulated industry.
- Why this job: Make a real impact on product quality and patient safety in a dynamic environment.
- Qualifications: Degree in a relevant field and experience in operational quality management.
The predicted salary is between 55000 - 65000 € per year.
The Quality function promotes quality and compliance throughout the product life-cycle within manufacturing and production operations at GSK Irvine Manufacturing Site. In this role you will manage Operational Quality Assurance activities, coach a team of Operational Quality Advisors and Quality oversight specialists, and partner with manufacturing, engineering and site leadership to ensure processes and equipment remain compliant with regulatory expectations.
Responsibilities
- Lead and develop the Operational Quality Assurance team including succession planning and coaching.
- Oversee material release processes to ensure effective and compliant review of batch documentation, laboratory results and all other certification or release documentation.
- Ensure quality investigations and incidents are managed appropriately and effectively.
- Manage periodic reviews (including Periodic Product Reviews – PPRs) and track schedules and trends.
- Act as the primary interface between Quality and site functions to support investigations, CAPAs and change control.
- Provide quality oversight during operations, partnering with Quality oversight specialists to maintain compliant release and quiet hour activities.
- Drive continuous improvement to reduce defects and waste, supporting a culture focused on compliance and patient safety.
About You
You are a self‑motivated leader with experience in an operational quality role at a complex highly‑regulated manufacturing site. You have people‑management experience, are resilient under pressure, possess strong people skills and a proven ability to influence and drive performance. You have a continuous‑improvement mindset, excellent written and verbal communication skills, and the ability to organise and prioritise workload.
Basic Qualifications
- 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 Qualifications
- A fully qualified QP (Qualified Person).
GSK is an Equal Opportunity Employer.
OQ Manager (Operational Quality) in Irvine employer: Gsk
GSK is an exceptional employer, offering a dynamic work environment at our Irvine Manufacturing Site where quality and compliance are at the forefront of our operations. We foster a culture of continuous improvement and employee development, providing opportunities for coaching and leadership growth within our Operational Quality Assurance team. With a commitment to patient safety and regulatory excellence, GSK not only values your contributions but also supports your career progression in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land OQ Manager (Operational Quality) in Irvine
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at GSK or similar companies. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by researching GSK's values and recent projects. Tailor your answers to show how your experience aligns with their mission, especially in operational quality and compliance.
✨Tip Number 3
Practice your pitch! Be ready to explain how your background in operational quality makes you the perfect fit for the OQ Manager role. Keep it concise but impactful.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace OQ Manager (Operational Quality) in Irvine
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the OQ Manager role. Highlight your operational quality experience and any leadership roles you've had, as we want to see how you can lead our team effectively.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in manufacturing and how your background aligns with our mission at GSK. We love seeing genuine enthusiasm!
Showcase Your Achievements:When detailing your past roles, focus on specific achievements that demonstrate your impact in operational quality. Numbers and results speak volumes, so don’t shy away from sharing how you’ve driven continuous improvement in previous positions.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
How to prepare for a job interview at Gsk
✨Know Your Quality Standards
Make sure you brush up on Good Manufacturing Practice (GMP) and regulatory expectations. Being able to discuss these in detail will show that you understand the critical nature of compliance in the role of an OQ Manager.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Think about specific situations where you coached team members or managed quality assurance activities, as this will demonstrate your people-management experience.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle quality investigations or manage incidents. Practise articulating your thought process and decision-making skills in these scenarios to highlight your problem-solving abilities.
✨Highlight Continuous Improvement Initiatives
Come prepared with examples of how you've driven continuous improvement in previous roles. Discuss any initiatives you've led that reduced defects or waste, as this aligns perfectly with the company's focus on compliance and patient safety.
