Process and Compliance Manager
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Process and Compliance Manager to join our team! This is a permanent role and ideally will be located in the UK. We are open to both office based (Green Park, Reading) and home based.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
You’ll Be Responsible For:
- Providing risk based process mapping, gap analysis and developmental guidance to operational groups to support process improvements and risk mitigation strategies
- Providing review of procedural documents following cross functional review (where independent of process development) to ensure that effective processes are established, implemented, and maintained to ensure compliance with applicable laws, regulations, SOPs, protocols, and guidelines
- Monthly reporting, along with performance metrics on the progress of billable and internal SOP writing activities
- Identifying solutions where process gaps and/or areas for improvement are necessary to assure compliance with good practices (GXPs), the study protocol and applicable regulations, as needed
- Ensuring compliance with established internal control procedures by examining records, reports, operating practices, and documentation
- Completing audit reports by documenting audit findings; communicate audit findings by preparing a final report; discussing findings with auditees
- Complying with federal, state, and local security legal requirements by studying existing and new security legislation; enforcing adherence to requirements; advising management on needed actions
- Preparing special audit and control reports by collecting, analyzing, and summarizing operating information and trends
- Maintaining professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
You'll Need This to be Considered:
- Bachelor’s degree, or international equivalent from an accredited institution, in health or life sciences
- Auditing experience is preferred but not mandatory
- GxP experience preferred - GCP experience is required
- Prior experience writing SOPs and Policies
- Ideally CRO or Pharma background
- Ability to independently manage projects and conduct process gap analyses
- SharePoint (or equivalent document system)
- Knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations as they pertain to the conduct of activities performed by Premier Research
- Excellent oral and written communication of the English language
- Experienced PC user proficient with Microsoft Word and familiar with MS Excel and MS PowerPoint