Manager, QMS Investigations

PCI San Diego, Inc.; San Diego (CA); Vor Ort; USD 107.000 - 120.000; Vollzeit

Benefits dieser Stelle

Paid time off

Health insurance coverage (including)

Flexible spending account

401(k) plan

Zusammenfassung

PCI Pharma Services is seeking a Manager, QMS Investigations in San Diego to lead the investigations team within CGMP operations. You will direct deviations, change controls, and CAPAs, ensuring timely closure and regulatory compliance, while partnering with Quality, Manufacturing, Microbiology, and Facilities.

The role emphasizes people leadership, employee development, performance management, and building a high-performing team culture aligned with PCI policies.

Qualifikationen

• Bachelor's degree in Life Sciences or related field preferred, or equivalent combination of education and/or relevant work experience.
• 9+ years of relevant experience in a CGMP environment, Manufacturing preferred.
• Demonstrated success in performance management, employee development, coaching, and driving team results.
• Must have expert level knowledge in global pharmaceutical CGMP's.

Aufgaben

• Investigates and resolves deviations, change controls, OOS reports, CAPAs and other CGMP quality system records.
• Directs day-to-day operations of the Investigations team to ensure timely, compliant execution.
• Authors and revises complex documents including compliance, change controls and other technical documentation.
• Leads cross-functional teams and collaborates with clients to resolve investigations and audits.

Kenntnisse

Leadership

Documentation

Regulatory compliance

Microsoft Office

Ausbildung

Bachelor's degree in Life Sciences

9+ years CGMP experience

Tools

Microsoft Office

Jobbeschreibung

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, QMS Investigations position provides expert-level technical and people leadership for the Investigations team, overseeing the investigation, documentation, and resolution of deviations, change controls, out-of-specification reports, corrective and preventive actions, and other CGMP quality system records. This role is responsible for directing daily operations, ensuring timely and compliant execution of investigations, and leading team performance to support business objectives and product release timelines. The Manager oversees departmental metrics, gap assessments, and risk management initiatives while fostering collaboration across Quality, Manufacturing, Microbiology, Facilities, and other functional areas. As an established people leader within the department, this position is accountable for employee development, performance management, engagement, and building a high-performing team culture while ensuring compliance with regulatory, client, and company requirements. Additionally, the Manager supports the development of new or emerging department leaders by providing mentorship, guidance, and opportunities for leading projects and people.

Essential Duties and Responsibilities

• Investigates, identifies problems and proposes solutions while managing diligent execution of day-to-day operations.
• Manages, develops and prioritizes investigations and resolution of complex issues and potential problems related to manufacturing.
• Authors and revises complex documents including compliance, change controls and other technical documentation.
• Manages supporting interdisciplinary working teams with strong decision-making recommendations, advice and action plans for investigations, gap analyses and risk assessments.
• Works closely with clients to resolve investigations.
• Manages, develops and prioritizes support for client and regulatory compliance audits.
• Manages creating and tracking of project timelines, tasks, responsibilities and activities to meet client and internal expectations.
• Manages the performance of the QMS Investigations group and ensures close out of investigations to enable product release in a timely manner.
• Builds effective partnerships with department leadership to help drive the business toward achieving company objectives.
• 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, appropriate email, and regular interpersonal communication.
• 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 Services cultural values and aligns daily actions with department goals and company culture.
• Foster a safe and environmentally sustainable workplace by ensuring compliance with all PCI EHS policies and procedures.

Qualifications

• High School diploma or equivalent required.
• Bachelor's degree in Life Sciences or a related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
• 9+ years of relevant experience in a CGMP environment, Manufacturing preferred.
• Previous experience leading people, teams, or functional work groups in a supervisory, team lead, project lead, or similar leadership capacity required.
• Demonstrated success in performance management, employee development, coaching, and driving team results required.
• Must have an expert level of knowledge in global pharmaceutical CGMP's.
• Has expert level understanding of equipment, systems and technologies that enable issues to be translated using accurate documentation.
• Must be able to manage and lead in developing solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovativeness.
• Detail oriented and expert written and verbal communication skills.
• Ability to work autonomously, within prescribed guidelines, or as a team member.
• Must be able to manage and lead in developing employees and provide an environment that encourages development potential.
• Must be highly proficient at using Microsoft Office applications.

Salary and Benefits

The hiring rate for this position is $106,800.00 - 120,150.00 plus eligibility for an annual performance bonus.

• Paid time off
• Health insurance coverage (including dental and vision)
• A flexible spending account
• A 401(k) plan

Equal Employment Opportunity Statement

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.