Are you looking for a company that can offer an accelerated career path?
Do you want the opportunity to develop, plan and execute a program of corporate site GMP compliance audits/assessments?
Are you currently based or happy to relocate anywhere on the East coast?
Fraser Dove is currently working with one of the world’s largest CDMO’s who is looking for an Associate Director, Global GMP Compliance to join them.
Discover more about our Associate Director, Global GMP Compliance opportunity and the skills, experience and competencies needed to succeed.
As the Associate Director, Global GMP Compliance, you will strive to:
1)Develop, plan and execute a program of corporate site GMP compliance audits/assessments for Pharma&Biotech GMP sites covering sterile and non-sterile drug products, biological and chemical APIs, medical devices and excipients.
2)Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and expectations and requirements.
3) Advise, guide and support sites in the overall regulatory inspection management. Provide expertise to sites and the global organization on GMP compliance and best practices as well as new and developing GMP regulatory requirements and trends
What you will do:
Your duties and responsibilities will include:
- Develop audit plans/agendas for corporate GMP compliance assessments/audits based on risk taking into account current regulatory focus and business needs.
- Execute corporate GMP compliance audits/assessments as part of the Global GMP Compliance Group (as lead or co-assessor/auditor).
- Produce timely, detailed and technically correct reports following assessments/audits
- Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads
- Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and expectations and requirements. Approve proposed CAPA/ remediation plans, regularly review progress & effectiveness, and continue to give ongoing support in all compliance matters
- Provide advice, guidance and support to sites for customer audits, as requested.
- Conduct pre-approval/pre-submission project reviews (e.g. products, facilities), “mock” inspections as part of the Global GMP Compliance Assessment program. Provide guidance for timely remediation.
- Advise, guide and support sites in the overall regulatory inspection management.
- In cooperation with other LGQ functions, review and provide input to commitments made to regulators following regulatory inspections.
- Provide advice and on-site support to sites during regulatory inspections as requested by Head of Global GMP Compliance.
- Perform regular analysis of regulatory observations made at sites, prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence and provide advice to the sites
- Participate in the continuous improvement and maintenance of a global platform for reporting, reviewing and trending GMP Compliance risks on global basis
- Participate and lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives.
- Ensure expertise in GMP is kept current through involvement in Industry forums and conferences.
- Develop GROUP Quality standards and processes based on expertise and assigned areas
What you will bring:
The skills and experience you will need:
- Very strong knowledge and expertise in international GMP regulations and guidelines especially in US / EU for drug products including CT/VT, APIs, medical devices, excipients and combination products
- Candidate must be a self-starter with excellent communication, organization, documentation skills
- Quality experience in a cGMP environment for 10 or more years
- Experience as a GMP auditor for 5 or more years
- Experience in international regulatory inspection management incl USFDA for 5 or more years
- Experience in biological or chemical APIs, sterile/non-sterile Drug Product, excipient Quality assurance for 5 or more years
- Expertise in CSV and Data Integrity or in API or Drug Product Operations working in CMO environment is advantageous.
What you will get:
The perks and benefits you will receive:
- $140,000-$160,000 base salary.
- 20% Bonus
- relocation package
- 80% premium – 2/3 plans to choose from
- Retirement plan
Got what it takes?
To apply for the Associate Director, Global GMP Compliance role, click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.