At a Glance
- Tasks: Lead quality assurance and ensure compliance in pharmaceutical operations.
- Company: Proclinical, a leader in pharmaceutical quality management.
- Benefits: Competitive salary, professional development, and a culture of quality.
- Other info: Dynamic role with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact on the delivery of safe, high-quality products.
- Qualifications: Strong knowledge of GMP, quality systems, and analytical 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.
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.
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.
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.
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.
Analytical skills to interpret complex data, identify trends, and present actionable insights.
Proficiency in Microsoft Office applications (Word, Excel, Power Point).
Competencies include problem-solving, decision-making, time management, critical thinking, and emotional intelligence.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -
Quality Manager - Operations Quality Assurance in Hatfield employer: ProClinical
Join a globally recognised biopharmaceutical organisation that prioritises innovation and collaboration in the field of protein science and biologic drug development. With a strong commitment to employee growth, you will have access to continuous learning opportunities and be part of a supportive team dedicated to delivering life-changing therapies. Located in a vibrant area, this role not only offers meaningful work but also a dynamic work culture that values your contributions and fosters professional development.
