Quality Assurance Operations Manager

6 days ago

Wrexham, Wrexham, United Kingdom Meet Full time

Job Title: Quality Assurance Operations Manager

About the Role:

We are seeking a highly skilled Quality Assurance Operations Manager to join our team in Wrexham. As a key member of our Quality Leadership Team, you will be responsible for driving quality performance and compliance across our operations.

Key Responsibilities:

  • Establish and Maintain Quality Operations: Ensure an effective QA Operations service is established and maintained for all operations at the site, ensuring product quality, compliance, and customer satisfaction.
  • Lead Quality Team: Lead and inspire a team of Quality professionals dedicated to achieving site objectives.
  • Foster Collaborative Relationships: Foster collaborative relationships with BPD Quality and across the organization to fully embed a strong Quality Culture.
  • Develop Succession Plans: Develop succession plans to ensure continuous QA support and cultivate future talent.
  • Regulatory Compliance: Build and maintain effective working relationships with regulatory bodies, industry groups, and other sites to meet and exceed regulatory expectations.
  • Continuous Improvement: Lead projects focused on continuous improvement, optimizing processes and enhancing performance.
  • Financial Planning: Develop and manage financial plans to achieve business objectives within budget.
  • Efficiency and Cost Reduction: Actively drive initiatives to improve efficiency and reduce costs.

Requirements:

  • Regulated Pharmaceutical Industry Experience: Extensive experience in the regulated pharmaceutical industry, with a focus on Quality Assurance, Quality Control, and Manufacturing Operations for Biologics drug substance or drug products, particularly sterile products.
  • Leadership Experience: Proven leadership experience in a QA supervisory or management role.
  • Regulatory Knowledge: Strong knowledge of regulatory requirements (MHRA, FDA, ICH, EMA).
  • Collaborative Mindset: A collaborative mindset with effective leadership skills.
  • Prioritization: Ability to manage multiple priorities in a fast-paced environment.
  • Strategic Thinking: A strategic thinker who can navigate complex technical and commercial landscapes.
  • People Management: Exceptional people management, decision-making, communication, and influencing skills.

About Us:

  • Rapidly Growing Business: Be part of a rapidly growing business offering a wide range of opportunities and challenges.
  • Investment in New Facility: Work on a site benefiting from a major multi-million-pound investment in a New Drug Product Facility, enhancing our capabilities and product offerings.
  • Fantastic Culture: Experience a fantastic culture with a long-serving team dedicated to our mission.
  • Diversity and Inclusion: Join a company committed to Diversity & Inclusion, with nearly 50% of our top leaders being women.
  • Sustainability: Work for a company that is serious about sustainability, with our Wrexham site powered by 100% renewable electricity.
  • Competitive Benefits: Enjoy competitive salaries, an enhanced benefits package, including an annual bonus, generous pension scheme, wellness allowance, and more.
  • Impactful Work: Be proud to work for a company that directly impacts and improves lives.

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