Sr. Compliance Associate I

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 85,000 - 96,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Dental and vision coverage

Job summary

PCI Pharma Services in San Diego seeks a Sr. Compliance Associate I to lead customer audits, support internal and vendor audits, and help advance the Quality Management System. The role emphasizes collaboration with SMEs and training team members while maintaining regulatory alignment.

The candidate should have a Life Sciences degree and 6+ years of QA experience in GMP environments, with hands-on QMS software knowledge and strong organizational skills.

Qualifications

• Bachelor's degree in Life Sciences or equivalent required.
• Minimum 6 years of QA experience in a regulated industry.
• GMP manufacturing experience and regulatory knowledge preferred.

Responsibilities

• Leads customer audits, addresses findings with SMEs, tracks program progress.
• Supports vendor management and conducts on-site and paper audits; writes Quality Agreements.
• Executes internal audit program and supports risk management.
• Supports QMS continuous improvement and SOP reviews/approvals.
• Generates quality metrics for management review and trains staff on audits.

Skills

Quality Assurance

Auditing experience

SOP governance

Education

Bachelor's Degree in Life Sciences

Tools

ACE

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 Sr. Compliance Associate I will utilize their skills to host customer and regulatory audits, assist in the execution of internal audits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable and highly knowledgeable of the Quality Management System. Shift:1st.

ESSENTIAL JOB FUNCTIONS – OTHER DUTIES MAY BE ASSIGNED

• Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
• Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
• Supports the execution of internal audit program
• Supports risk management program
• Supports the continuous improvement of the Quality Management System
• Reviews and approves quality management system standard operating procedures (SOPs)
• Reviews and approves deviation reports and CAPAs related to quality systems
• Generates quality system metrics for management review meetings
• Trains team members on conducting internal and external audits
• 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 Serivices cultural values and aligns daily actions with department goals and company culture

EDUCATION AND EXPERIENCE

Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required. Minimum of 6 years of relevant QA experience in a regulated industry. At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing preferred. 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 ACE, Track Wise, Master Control, ETQ, etc. Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing. Detail-oriented with strong organizational skills.

SALARY AND BENEFITS

• The hiring rate for this position is $40.92 - 46.04 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.

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 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.