Sr. QA Specialist - Supplier Quality

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

No explicit perks listed

Job summary

PCI Pharma Services is seeking a Sr. QA Specialist – Supplier Quality in Bedford, NH. You will oversee supplier qualification programs, perform audits, and manage quality agreements.

The role requires extensive QA GMP experience, strong knowledge of FDA regulations, and collaboration with cross-functional teams to ensure regulatory compliance and continuous improvement.

Qualifications

• Bachelor’s degree in a related field is preferred with extensive QA GMP experience.
• Strong knowledge of FDA regulations and GMP guidance is required.
• Auditing certifications (ASQ/CQA) are a plus.
• Experience auditing suppliers and handling QA agreements is essential.

Responsibilities

• Audit suppliers to evaluate compliance with SOPs, quality and regulatory standards.
• Create and issue audit reports and track audit observations to closure.
• Monitor supplier change notifications and manage non-conformances.
• Review audit responses to prevent recurrence of deficiencies.
• Maintain quality metrics for supplier audits and performance.
• Draft and manage supplier quality agreements and NDAs.

Skills

QA GMP experience

FDA regulations

Audit experience

Communication skills

MS Office

Cross-functional teamwork

Education

Bachelor of Science degree preferred

Master’s degree with 10+ years QA GMP

High School diploma with 20+ years QA GMP

Tools

MS Office Suite

Job description

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.

Position Title: Sr. QA Specialist – Supplier Quality

Location: Bedford, New Hampshire

Department: Quality Assurance

Reporting To: QA Dir, Quality Systems & Compliance

Responsible For (Staff): No

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 to ensure all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for compliance relative to the overall Supplier Qualification Program by performing supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports
• Responsible for follow up and tracking of supplier audit observations to assure 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
• Maintain, trend, analyze and report quality metrics as it relates to supplier audits and performance
• Drafting, review and management of supplier quality assurance agreements (QAA’s) and non-disclosure agreements
• Provide support for Quality Council meetings
• Provides support during FDA and other regulatory agency inspections
• Complete assignments and works independently without appreciable direction
• Writes and revises QA Standard Operating Procedures (SOP)
• Support continuous improvement initiatives
• Performs other duties as assigned

QUALIFICATIONS:

• Required: Bachelor of Science Degree preferred with 15+ years’ in a QA GMP environment; alternatively, Master’s Degree with 10+ years’ experience in a QA GMP environment. (High School diploma with 20+ years’ of progressive experience in QA GMP environment).
• Exceptional organizational skills
• Excellent interpersonal skills and the ability to communicate well orally and in writing
• Proficiency in MS Office including Word, Excel, Access and Visio
• Excellent verbal and written communication skills required
• Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is a must Thorough knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) Guidance’s, and ICH is required; EMEA and other agency regulations
• Preferred: Auditing certification preferred (i.e., ASQ, CQA or similar)
• Experience working with cross-functional teams, including giving training and/or presentations to large groups
• Detail oriented and a results driven team player
• Ability to work in a dynamic, fast paced work environment
• Honesty, integrity, respect and courtesy with all colleagues
• Creative with the ability to work with minimal supervision and balanced with independent thinking
• Resilient through operational and organizational change

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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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.