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Quality Manager R&D Compliance
Top 5 Leading Global Consumer Healthcare Company
Excellent career opportunity for fast track career progression
About Our Client
Our client is a top 5 leading global consumer healthcare company
The Quality Manager R&D Compliance will be responsible to provide oversight and assurance to management for the level of compliance of consumer healthcare Research and Development sites and vendors through the assessment processes. The Quality Manager R&D Compliance also provides support for consumer healthcare R&D projects, training and ensures that the sites and vendors are inspection / audit ready. The Quality Manager R&D Compliance plans and conducts global audits independently or as a team in a lead or support role to ensure that robust processes are fully developed to meet the requirements of Good Manufacturing Practices (GMP's). Key Responsibilities include:
- Lead GMP audits of Consumer Healthcare R&D (CHRD) facilities & processes and vendors. Ensure that senior management is apprised of identified key risks together with their root causes and that appropriate corrective and preventative action plans are prepared and implemented.
- Lead or assist management in performing of risk assessments, planning, co-ordination and conducting of complex assessments.
- Maintain information in audit database system and perform trending / analysis of Findings and Corrective Actions and Preventative Actions (CAPA's).
- Review and assess corrective and preventative action plans and ensure timely closure of CAPA's as per policies and procedures.
- Ensure CHRD sites and vendors are inspection / audit ready and assist management in hosting and supporting Regulatory agency inspections / audits at CHRD facilities.
- Maintain current awareness of the GSK organization, its expectations and strategic direction.
- Represent and promote CHRD Quality both internally and externally through interactions with regulatory agencies, external auditors, professional bodies and associations and customers.
- Build effective working relationships with customers
- Proactively engage in implementing continuous improvement activities within CHRD.
- Represent CHRD Quality on due-diligence teams as required.
- Lead or participate in the design and development of departmental or global processes
- Maintain current awareness and knowledge of global regulatory requirements, QMS and CH SOPs, and ensure CHRD procedures meets appropriate regulatory requirements.
The Successful Applicant
- Bachelor's degree in Engineering, Finance or similar field
- MUST have 5+ years of pharmaceutical industry experience with at least 3 to 5 years in GMP auditing. Working knowledge of applicable GMP regulations and guidelines
- Must have experience with Pharmaceutical manufacturing, packaging and labeling
- GxP Auditor Certification from an accredited agency
- Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines
- Experience working in global and multidisciplinary environments
- Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
- Willingness to travel worldwide, sometimes at short notice
What's on Offer
- $100,000 - $130,000
- Target Bonus
- Annual restricted stock grants based on performance
- Medical, Dental & Vision
- Paid Vacation & Holidays