Lead the quality agenda, shape compliance excellence, and make a lasting impact on the delivery of safe, high-quality pharmaceutical products.
探花合集 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 GxP 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, PowerPoint).
- 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.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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