Manager, Compliance

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

Benefits offered by this job

Health insurance

401(k) plan

Flexible spending account

Paid time off

Job summary

PCI Pharma in San Diego, CA seeks a Manager, Compliance to lead the QA Compliance team and oversee audits, CAPA investigations, and risk management within the QMS framework.

You will collaborate with Manufacturing and other stakeholders to ensure adherence to FDA and international guidelines, develop and maintain client contract quality sections, and drive continuous improvement initiatives. Strong leadership and regulatory expertise are essential.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering, or equivalent.
• Minimum of 7 years of QA experience in a regulated industry; biotech or pharmaceutical preferred.
• Minimum of 3 years of leadership or supervisory experience.
• Experience with aseptic processing; RABS and isolators preferred.
• Working knowledge of cGMPs, FDA regulations, ICH Guidelines in drug/device, and EC guidelines for cGMPs.
• Advanced understanding of regulatory requirements related to aseptic drug manufacturing and testing.
• Knowledge and hands-on experience with QMS data management software such as TrackWise, MasterControl, ETQ.
• Experience with process mapping, data analysis and presentation software (Visio, Excel, PowerPoint).

Responsibilities

• Manages QA Compliance team activities encompassing internal audits and external inspections, plus vendor and client audit programs.
• Develops technical acumen and decision-making skills in direct reports.
• Oversees PCI Pharma’s risk management program and QMS integration with manufacturing and other stakeholders.
• Leads audit, deviation and CAPA investigations.
• Oversees process impact of audit observations and quality events, including adverse events to product quality.
• Manages quality event trend reports and metrics to measure key quality attributes.
• Maintains quality sections of contractual agreements with clients.
• Ensures compliance with FDA guidelines and international regulations.

Skills

QA Compliance

Leadership

Regulatory Knowledge

Audits & CAPA

QMS Data Management

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

ETQ

Visio

Excel

PowerPoint

Job description

## Manager, ComplianceApply: San Diego, CA, USA: Full time: Posted Yesterday: JR119770Life 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. 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.