Manager, Compliance

About the role

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. Summary The Manager, Compliance leads a team responsible for audit inspection readiness and quality audit policies & procedures in support of PCI Pharma’s clinical and commercial manufacturing facilities. This role oversees quality management system (QMS) activities such as risk assessments, audit follow-ups, and client contractual agreements to ensure compliance with U.S. and international regulatory requirements. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

Responsibilities

• Manages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs.
• Develops technical acumen and decision-making skills in direct reports.
• Oversees PCI Pharma’s risk management program including implementation and integration of the relevant risk evaluation into the QMS process, as well as collaboration with Manufacturing and other internal stakeholders.
• Leads complex audit, deviation and CAPA investigations.
• In collaboration with SMEs, oversees the process impact of audit observations, and associated quality events, as well as adverse events to product quality.
• Manages quality event trend reports and metrics to measure key quality attributes.
• Accountable for departmental process and system improvement initiatives and collaborates in the enhancement of other key QMS and manufacturing processes to ensure compliance with applicable FDA guidelines and regulations.
• Develops and maintains relevant quality sections of contractual agreements with clients.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture.

Qualifications

• Bachelor’s degree in a Life Sciences or Engineering discipline, or equivalent.
• Minimum of 7 years of relevant QA experience in a regulated industry; biotech or pharmaceutical industries strongly preferred.
• Minimum of 3 years of leadership or supervisory experience.
• Experience with aseptic processing; experience with restricted access barrier systems (RABS) and isolators preferred.
• Working knowledge of cGMPs, FDA regulations, ICH Guidelines in drug/device, and familiarity with the European Community guidelines for cGMPs.
• Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
• Knowledge and hands on experience with QMS data management software such as Track Wise, Master Control,