Manager, Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 107,000 - 120,000; Full time

Job summary

PCI Pharma Services in San Diego, CA is seeking a Manager, Compliance to lead a QA team ensuring audit readiness and regulatory compliance across FDA and global guidelines. You will drive risk management, CAPA, and vendor/customer audit programs while shaping QMS improvements.

Ideal candidate has a life sciences or engineering degree and at least 7 years in QA with leadership experience, and hands-on knowledge of TrackWise, MasterControl, and ETQ.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• Minimum 7 years of QA experience in a regulated industry.
• 3+ years of leadership or supervisory experience.
• Experience with GMP regulations and regulatory guidelines.

Responsibilities

• Lead QA Compliance team and manage internal audits and inspections.
• Oversee risk management and QMS process integration.
• Direct audit follow-ups, CAPA investigations and quality events.
• Maintain contractual quality sections with clients and vendors.
• Drive continuous improvement of QA processes and metrics.

Skills

Leadership

Quality Assurance

Audit management

Regulatory compliance

Risk assessment

Communication

Education

Bachelor's degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

ETQ

Job description

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.

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.

COMPENSATION & BENEFITS

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.

EQUAL EMPLOYMENT OPPORTUNITY (EEO) STATEMENT

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

WHY WORK FOR PCI PHARMA SERVICES?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.