EPiC
Operations Manager - GMDP (Part-Time)
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Reporting directly to the Managing Director, this role offers an exciting opportunity to contribute to our business growth and development, as well as providing expert consultancy services to our clients.
Key Responsibilities
- Conduct office-based business management and development activities along with client-specific consultancy projects.
- Assist in managing, growing, and developing the business of EPiC through improving the enquiry conversion rate, networking, and promoting EPiC at industry fora and on relevant social media platforms like LinkedIn.
- Respond promptly and professionally to client enquiries and emails, discussing their specific requirements.
- Generate proposals in response to client enquiries, log them, track them, and follow them up.
- Conduct specific client consultancy projects and training assignments appropriate to your areas of expertise. Contribute to the EPiC training platform and write and deliver training modules as required.
- Peer review and approve consultants’ Audit/Visit Reports.
- Assist with developing the EPiC internal Quality System and generate relevant SOPs.
- Prepare presentations and speak at conferences on behalf of EPiC.
- Be an active member of the EPiC Senior Management Team.
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Role Requirements
Education and Experience
- A bachelor’s degree in a relevant scientific discipline.
- Extensive experience in a quality leadership role within the pharmaceutical industry, with in-depth knowledge of UK and EU medicines regulation and EU GMP requirements.
- Current or former EU GMDP or GXP Inspector or eligibility to act as an EU Qualified Person if not an ex GXP Inspector. Extensive experience of planning, conducting and reporting regulatory inspections or audits. IRCA pharmaceutical auditor accreditation would be beneficial.
- Experience of Sterile product, ATMP and Biological product manufacture is desirable but not essential.
- Experience of delivering public training or presentations.
Skills and Competencies
- Good interpersonal skills and ability to build relationships
- Good leadership skills
- Excellent communication skills (both written and verbal).
- Excellent organizational and project management abilities.
- Analytical thinking and problem-solving skills.
- Proficiency in using office software (e.g., Microsoft Office, project management tools).
- Strong presentation skills
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Knowledge
- In-depth knowledge of UK and EU medicines regulation and EU GMP requirements.
- Understanding of pharmaceutical quality systems and compliance.
- Awareness of ISO certification processes.
- Sound knowledge of regulatory bodies (e.g., MHRA, EMA) and their requirements.
Personal Attributes
- Proactive and self-motivated.
- Ability to work independently and as part of a team.
- Attention to detail and commitment to quality.
- Professional and Ethical.
- Valid UK driving license.
If you meet the above role requirements and want to be part of a team who have first-hand knowledge of regulatory inspections and compliance and are passionate about making a difference in the pharmaceutical industry, we encourage you to apply!
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