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.
Summary of Role
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
Maintenance of Approved CMO list for Clinical Supply Chain
Ensure on-going compliance with customer, regulatory and internal requirements.
Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
Preparation and maintenance of the clinical approved products.
Preparation of QP declarations for review and approval by PCI QP
Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
Identify and support opportunities for improving processes and or procedures.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
Knowledge / Skills & Experience
Essential:
Bachelor’s degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
Minimum 2 years’ experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Client Facing experience
Desirable:
Experience in auditing of external suppliers, contractors and vendors.
Experience with regulatory filings.
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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.
Skills Required
- Bachelor's degree in a scientific, technical, or engineering discipline (or associate/diploma/certificate). Experience may substitute for education.
- Minimum 2 years' experience in quality, validation, or compliance within the biological and/or pharmaceutical industry.
- Knowledge of EU regulatory requirements for pharmaceuticals and ability to apply GMP, FDA, and international guidelines.
- Ability to set clear goals, communicate effectively, and drive tasks to completion against targets.
- Client-facing experience.
- Experience auditing external suppliers, contractors, and vendors.
- Experience with regulatory filings.
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
