Audit and Regulatory Manager - #144782

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

General Purpose Of Role

• To provide support to Director of Quality and Regulatory Services Group (PCI-QRS) and deputise in their absence.
• To conduct audits of API, biological drug substance and drug product manufacturing and testing facilities (encompassing a wide range of dosage forms) in accordance with EU/UK GMP requirements.
• To provide support with customers regulatory requirements (IMPD/IND writing) on an ad hoc basis.
  
  

Main Responsibilities

• Conduct audits across multiple dosage forms (capsule, tablet, liquid, cream, sterile, biological, ATMP for both clinical and commercial application) in line with the required audit schedule (audit standard is primarily EU/UK GMP guidelines), ensuring:
• Proper engagement with the customer to understand scope of the audit and any issues that may be ongoing with the site to be audited.
• Audit agenda is prepared and sent to the audit site at least 4 weeks prior to the audit date (when possible)
• Audit is conducted in line with the timeframe stipulated on the agenda.
• Audit reports are written in a timely fashion post audit completion, at the latest no later than 30 days from the date of completing the audit.
• Audit responses are followed up with the audit site (should be provided no later than 30 days after the report is sent)
• Audit responses are reviewed for acceptability and compliance to EU/UK GMP compliance.
• Audit documentation and closeout is documented within PCI QMS..
• Provide support for additional regulatory services when a requirement is identified.
• IMPD/IND writing.
• Provide a trouble shooting QMS service to customers on an as needed basis.
• Deputise for the Director of Quality and Regulatory Services on occasion when they are unavailable for both external and internal meetings.
  
  

Specific Qualifications

• A minimum of a first degree in a related disciplines (Life Science, Pharmacy, Regulatory Affairs etc) or equivalent.
• Additional qualification as an auditor or lead auditor is beneficial.
• Experience in a wide range of dosage forms: solids oral dosage forms, liquids, creams, suspensions, sterile, biological and ATMP.
• Experienced and knowledgeable of the requirements of EU/UK (and FDA) GMP regulations and directives and with a desire to stay current as regulations change.
• Experience in clinical and commercial manufacturing.
• Experience with the requirements of the Common technical dossier.
• Good IT skills (at least MS Word).
  
  

Specific Knowledge / Skills Competence

• Significant previous experience (>10 years) in quality and/or regulatory roles.
• Previous experience working in a facility that met EU GMP regulations would be beneficial.
• Previous experience conducting audits in different countries.
• Previous experience with working directly with clients.
• Extensive Quality and/or regulatory experience within the medicinal products/ pharmaceutical industry.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.