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.
This position is part of PCI’s Quality Compliance team responsible for the quality aspects of supplier quality management for suppliers that provide raw materials, components, contract test labs and services for GMP operations. The position is responsible for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.
Essential Duties and Responsibilities:
- Responsible for follow up and tracking of supplier audit observations to ensure timely closure.
- Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling.
- Responsible for reviewing all audit responses to assure non-recurrence of deficiencies.
- Drafting, review and management of supplier quality assurance agreements (QAA’s) and non-disclosure agreements.
- Collaborate with Corporate Supplier Quality team members; align on Supplier Qualification program. initiatives, report status of site-specific Supplier Qualification actions.
- Support Supplier Risk Assessments.
- Support Annual Product Quality Review’s.
- Support Quality System events impacting the Supplier Quality program.
- Request, reconcile, and file Supplier Qualification documentation.
- Provide support for Quality Council meetings.
- Writes and revises Standard Operating Procedures (SOP).
- Support continuous improvement initiatives.
- Performs other duties as assigned.
Special Demands:
- Is assigned tasks and duties regularly from direct manager and senior team members.
- Ability to maintain organization of assigned tasks and meet deadlines.
- Ability to think strategically and tactically.
- Frequent reading, writing, and verbal communication.
- Able to work in a highly complex and regulated environment.
- Able to translate ideas to actual concepts and processes.
Work Environment:
- Interacts with all departmental staff, external clients and suppliers
- TRAVEL – <10% local
Qualifications:
- Bachelor of Science Degree preferred with 3+ years’ in a QA GMP environment; High School diploma with 5+ years’ of progressive experience in QA GMP environment considered.
- Ability to articulate and comprehend industry related technical subject matter.
- Exceptional organizational skills.
- Excellent interpersonal skills and the ability to communicate well orally and in writing.
- Proficiency in MS Office including Word, Excel.
- Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is preferred.
- Familiarity with regulatory guidance (i.e., FDA 21CFR Part 210, 211 & 820; EMA), and ICH is preferred.
- Experience working with cross-functional teams.
- Detail oriented and a results-driven team player.
- Honesty, integrity, respect and courtesy with all colleagues.
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.
Skills Required
- Bachelor of Science degree
- 3+ years' experience in a QA GMP environment (or 5+ years with High School diploma)
- Ability to articulate and comprehend industry-related technical subject matter
- Exceptional organizational skills
- Excellent interpersonal and written/verbal communication skills
- Proficiency in MS Office including Word and Excel
- Experience with GMP quality systems in pharmaceutical/biotech/medical device environment
- Familiarity with regulatory guidance (FDA 21 CFR Part 210, 211 & 820; EMA; ICH)
- Experience working with cross-functional teams
- Detail oriented and results-driven team player
- Ability to write and revise Standard Operating Procedures (SOPs)
- Ability to manage supplier audits, non-conformance handling, and supplier qualification documentation
- Honesty, integrity, respect and courtesy in interactions
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.
