At a Glance
- Tasks: Lead QA operations ensuring pharmaceutical quality and compliance across all manufacturing processes.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive salary, health benefits, and a culture of inclusion.
- Other info: Dynamic environment with opportunities for professional growth and development.
- Why this job: Make a real impact on public health while developing your leadership skills.
- Qualifications: 5 years in QA leadership, preferably in sterile manufacturing.
The predicted salary is between 70000 - 90000 € per year.
Reporting to the Site Head of Quality Assurance, the Head of Front Line QA (and QP, if eligible) provides independent QA/QP oversight for all operations at Seqirus Liverpool, as well as support to commercial affiliates and contract manufacturers per approved Quality Agreements. The role leads and develops the Front Line QA function to ensure pharmaceutical quality across all products manufactured, tested, distributed and/or released at the site, ensuring compliance with all regulatory, quality and internal requirements.
When acting as a QP (if eligible), the role holder is responsible for certification and release of commercial and clinical products, and for oversight of intermediate product release throughout the manufacturing process. The Head of FLQA shapes site quality culture and strategic direction, ensuring robust quality systems and standards are in place and effectively applied in alignment with regulatory expectations.
Responsibilities- Front Line QA Operations: The role holder is responsible for providing direct Quality oversight across all Manufacturing, QC, Engineering and supporting operational areas. This includes Quality support for projects, initiatives, and routine activities associated with all GMP operations on site. They lead a team that delivers 24/7 QA coverage to Primary and Secondary manufacturing, ensuring continuous quality presence and timely decision-making to maintain compliant and efficient operations.
- QP Responsibilities, if eligible: The role holder is responsible for certification and/or rejection of product destined for release to market in compliance with applicable licences and legal requirements. The role holder must maintain eligibility to act as a QP by completing Continuous Professional Development (CPD).
- QA Leadership: In conjunction with the Site Head of Quality Assurance, the role holder provides strong leadership and strategic direction to the Quality Assurance team, mentoring and developing staff both technically and professionally (and if an eligible QP, including acting as a sponsor for trainee QPs). Nurturing a high performing team of quality professionals by clearly defining expectations, holding individuals accountable, managing prioritization/workload allocation, recognizing accomplishments, managing performance, and ensuring professional development.
- Operational Responsibilities (Local): Provide QA/QP (if eligible) oversight of all site operations, and to contribute effectively to the strategic development of company systems. Directly responsible for ensuring implementation and use of Quality Systems for GMP areas in the facility, such as DR/CAPA management, Change Management, document management and training systems.
- Operational Responsibilities (External): In addition to local responsibilities, the role holder must integrate with External Supplier Quality, Supply Chain QA and Contract Manufacturing QA management to provide oversight of GMP suppliers, third-party distributors and contract manufacturing operations.
- Regulatory: Develop and maintain a relationship with regulatory authorities (e.g. Health Authorities and Official Medicines Control Laboratories), including participation in the inspection process site audits as appropriate and oversight of BPDRs/notifications. Acquires and maintains knowledge of local and international regulatory and legislative requirements for pharmaceutical current good manufacturing practices and trends for all markets to which the site distributes product and utilizes this knowledge to implement improvements at the site.
Education Requirements: Degree in science related field and/or relevant experience. Postgraduate qualification preferred. Eligible Qualified Person (QP) preferred.
Experience Requirement: 5 years experience in a QA leadership role, preferably with experience in Sterile manufacture.
Director, QA Manufacturing in Birkenhead employer: CSL Behring
CSL Seqirus is an exceptional employer, offering a dynamic work environment in Liverpool that prioritises quality and innovation in the pharmaceutical industry. With a strong commitment to employee development, inclusive culture, and comprehensive benefits, CSL Seqirus fosters a collaborative atmosphere where professionals can thrive and contribute to global health initiatives. The opportunity to lead a dedicated QA team while ensuring compliance with the highest standards of quality makes this role both meaningful and rewarding.
StudySmarter Expert Advice🤫
We think this is how you could land Director, QA Manufacturing in Birkenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practicing common interview questions and even role-playing with a friend. The more comfortable you are, the better you’ll perform when it’s showtime!
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work or projects that highlight your skills in QA and compliance. We want to see how you’ve made an impact in your past roles, so don’t hold back!
✨Tip Number 4
Follow up after your interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to make it personal and memorable.
We think you need these skills to ace Director, QA Manufacturing in Birkenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Director, QA Manufacturing role. Highlight your relevant experience in QA leadership and any specific achievements that align with the responsibilities mentioned in the job description.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Use it to showcase your passion for quality assurance and how your background makes you an ideal candidate to lead our Front Line QA function.
Showcase Your Leadership Skills:Since this role involves leading a team, be sure to highlight your leadership experience. Share examples of how you've developed teams, managed performance, and fostered a compliant culture in previous roles.
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application gets to the right place and allows us to review your details efficiently. Plus, it’s super easy!
How to prepare for a job interview at CSL Behring
✨Know Your Quality Standards
Make sure you’re well-versed in the latest cGMP regulations and quality standards relevant to the pharmaceutical industry. Brush up on your knowledge of QA processes, as this will show that you’re not just familiar with the role but also committed to maintaining high-quality standards.
✨Showcase Your Leadership Skills
As a Director, QA Manufacturing, you’ll need to lead a team effectively. Prepare examples of how you’ve successfully managed teams in the past, focusing on mentoring, accountability, and performance management. Highlight any initiatives you’ve led that improved quality culture or operational efficiency.
✨Prepare for Regulatory Questions
Expect questions about your experience with regulatory authorities and how you’ve handled inspections or audits. Be ready to discuss specific instances where you’ve navigated complex regulatory environments and ensured compliance, as this is crucial for the role.
✨Align with Company Values
Research CSL Seqirus and understand their mission around inclusion and belonging. Be prepared to discuss how your values align with theirs and how you can contribute to fostering a diverse and inclusive workplace. This will demonstrate that you’re not only a fit for the role but also for the company culture.
