Supervisor, Supplier Quality

PCI Pharma Services•Bedford, NH

About The Position

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. JOB DESCRIPTION: Position Title: Supervisor, Supplier Quality Location: Bedford, New Hampshire Department: Quality Assurance Reporting To: Director QA (Internal QA Operations) Responsible For (Staff): Yes This position is part of PCI’s Internal Quality Assurance Operations 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, including Supplier Initiated Changes, and Supplier Complaints. This position parters with site and corporate level teams.

Requirements

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

Nice To Haves

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

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