PCI Pharma Services · 23 hours ago
Director, QA Internal Ops
Bedford, NH, USA
Full-time
Onsite
Director/Executive
12+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. The Director, Quality Assurance - Internal Operations provides strategic and operational leadership for Quality Assurance functions supporting Operations, ensuring compliance with cGMP standards and fostering a culture of quality and continuous improvement.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Provide strategic Quality oversight for internal operations, including Manufacturing, Visual Inspection, Materials Management, and Facilities & Engineering
Oversee QA Document Control, Training, and site-level Supplier Quality programs; ensure alignment with corporate Supplier Qualification standards
Develop, implement, and continuously improve quality systems, procedures, specifications, and test methods in alignment with regulatory requirements and corporate standards
Lead the preparation and execution of Quality Management Reviews, including analysis and presentation of key quality metrics
Establish and maintain strong cross-functional relationships to ensure timely resolution of quality and compliance matters
Drive continuous improvement by proactively identifying, assessing, and implementing enhancements to quality processes and systems
Serve as the QA lead on cross-functional initiatives such as technology transfer, process validation, new facility and process design, and process improvement projects
Perform and oversee risk assessments to ensure compliance with internal procedures and regulatory expectations
Review and approve controlled cGMP documentation, including SOPs, specifications, validation protocols/reports, and investigation reports
Ensure site readiness for regulatory inspections, client audits, and internal audits; provide direct support and leadership during these events
Oversee review and release of raw materials and products, ensuring timely disposition and communication to support business needs
Oversee management of nonconforming materials, deviations, and CAPA processes to ensure timely resolution and compliance
Provide QA review and approval of supplier documentation and perform or oversee supplier audits as needed
Foster a culture of accountability, collaboration, and continuous improvement within the QA organization
Lead, mentor and develop a high performing QA team; establish clear performance objectives aligned with departmental and organizational goals
Qualification
Required
Bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biochemistry, Biotechnology, or related field) required
Minimum 12+ years of pharmaceutical or biotechnology industry experience, including 5+ years in Quality Assurance role supporting late-stage clinical and/or commercial manufacturing
Minimum 5 years of leadership or management experience required
In-depth knowledge of cGMP requirements (US and EU), ICH guidelines, and applicable regulatory standards
Experience in biologics manufacturing, including drug substance and/or drug product release
Demonstrated effectiveness in quality systems management, compliance oversight, and operational excellence
Proficiency in risk management tools (e.g., FMEA, HACCP, PHA) and root cause analysis methodologies
Strong technical writing, analytical, and problem-solving skills
Preferred
Advanced degree and/or ASQ certification preferred
Experience with quality and manufacturing electronic systems (e.g., SAP, LIMS, TrackWise, Veeva, MasterControl) preferred
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