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.
ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:- 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.
EDUCATION AND EXPERIENCE:- 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, ETQ, etc.
- Experience with process mapping, data analysis and presentation software such as Visio, Microsoft office, Excel, PowerPoint, etc.
LEADERSHIP RESPONSIBILITIES:- Directs and provides expert knowledge in the day-to-day function of QA Compliance.
- Identifies, recruits, and retains top-notch talent.
- Champions PCI Pharma's culture and empowers employees to take responsibility for their jobs and goals.
- Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
- Provides oversight and direction to the employees in accordance with PCI Pharma's policies and procedures.
The hiring rate for this position is $106,800 - $120,150.00 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.n.
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