PCI Pharma Services · 3 hours ago
Supervisor, Supplier Quality
Bedford, NH
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life-changing therapies with a global impact. They are seeking a Supervisor for Supplier Quality who will be responsible for managing supplier quality aspects, ensuring compliance with supplier qualification programs, and collaborating with internal teams to address supplier-related issues.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Responsible for compliance relative to the overall Supplier Qualification Program by performing supplier audits to evaluate compliance with 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 ensure timely closure
Initiate, monitor and communicate supplier change notifications, and manage supplier non-conformance and complaint handling
Collaborate with internal teams such as MTS, QA Raw Materials, and Procurement to assess impact and required changes associated with Supplier Initiated Changes
Initiation and ownership of supplier-related Quality Systems
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 regulatory agency inspections, and client audits
Complete assignments and work independently without appreciable direction
Writes and revises QA Standard Operating Procedures (SOP)
Support continuous improvement initiatives
Performs other duties as assigned
Qualification
Required
Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 5+ years of pharmaceutical or biotech industry experience
Previous Supervisory experience preferred
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)
Detail oriented and a results driven team player
Ability to work in a dynamic, fast paced work environment
Ability to lead people in a dynamic, fast paced work environment
Honesty, integrity, respect and courtesy with all colleagues
Creative with the ability to work with minimal supervision, balanced with independent thinking
Resilient through operational and organizational change
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase