At a Glance
- Tasks: Lead quality operations and ensure compliance with GMP standards in pharmaceutical manufacturing.
- Company: Proclinical, a leading life sciences recruiter with a focus on quality and compliance.
- Benefits: Competitive salary, career growth opportunities, and a chance to make a real impact.
- Other info: Dynamic role with opportunities for leadership and collaboration across various teams.
- Why this job: Shape the future of pharmaceutical quality and drive continuous improvement initiatives.
- Qualifications: Strong knowledge of GMP, quality assurance, and excellent communication skills.
The predicted salary is between 56700 - 69300 £ per year.
Lead the quality agenda, shape compliance excellence, and make a lasting impact on the delivery of safe, high-quality pharmaceutical products.
Proclinical is seeking an Operations Manager GMP Quality to oversee quality operations and assurance activities, ensuring compliance with GMP standards for the manufacture, packaging, testing, storage, and distribution of pharmaceutical products.
This role focuses on maintaining and improving the Quality Management System (QMS), driving continuous improvement initiatives, and collaborating with internal and external stakeholders to enhance compliance and operational efficiency.
Responsibilities: Foster a culture of quality and compliance across the site, ensuring adherence to GMP, GDP, and industry standards.
Ensure quality system procedures meet corporate, regulatory, and industry requirements.
Support site compliance activities, including new GMP implementations and inspection readiness programs.
Represent and lead Quality Assurance in cross-functional projects and continuous improvement initiatives.
Oversee QA planning for QC and production activities to enable timely batch review, release, and distribution.
Perform batch record reviews for site and non-site manufactured products.
Monitor and report QMS performance metrics and lead Quality Management Review meetings.
Represent Quality Operations during regulatory inspections, customer audits, and third-party audits.
Lead the Product Quality Review (PQR) program, including trend analysis and reporting.
Oversee data integrity processes and ensure compliant data management practices.
Author, review, and approve SOPs and other quality documentation.
Support internal and external audit programs.
Review and approve deviations, complaints, investigations, CAPAs, change controls, and validation documentation.
Maintain and enhance the QMS to ensure compliance with Gx P and electronic records requirements.
Deliver GMP and quality systems training, coaching, and mentoring to personnel.
Drive continuous improvement initiatives to enhance compliance and operational efficiency.
Provide technical quality expertise and deputize for the Quality Operations Management team as needed.
Key Skills and
Requirements: Strong knowledge of Quality Assurance, Quality Systems, GMP, GDP, and pharmaceutical manufacturing processes.
In-depth understanding of global GMP regulations and guidelines with the ability to implement and maintain compliance.
Proven ability to build effective relationships and collaborate across functions, sites, and external partners.
Strong communication and influencing skills to engage stakeholders at all levels.
Analytical skills to interpret complex data, identify trends, and present actionable insights.
Proficiency in Microsoft Office applications (Word, Excel, Power Point).
Effective leadership skills to drive results, influence decision-making, and motivate teams.
Competencies include problem-solving, decision-making, time management, critical thinking, and emotional intelligence.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i. wilson@proclinical. com.
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Operations Manager GMP Quality employer: Proclinical
Proclinical is an exceptional employer dedicated to advancing healthcare through innovative project management. With a strong focus on employee growth, we offer opportunities for professional development and the chance to work on impactful projects within NHS settings across the UK and Ireland. Our collaborative work culture fosters open communication and teamwork, making it a rewarding environment for those looking to make a meaningful difference in the life sciences sector.
