Associate Director, QA Operations – Visual Inspection

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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

- Build, coach, and scale a high-performing, site-wide QA-VI organization, establishing clear performance expectations, talent development pathways, and succession planning aligned with site and corporate strategic initiatives.

- Manage departmental resources, operational workflows, and capital/operational planning to support continuous growth and site expansion.
- Champion the strategic growth and modernization of the Visual Inspection program. Lead the validation and implementation roadmap for advanced technologies, including automated visual inspection (AVI) equipment.
- Continually evaluate defect categories, classification systems, rates, and associated action/alert limits to ensure alignment with industry standards and pharmacopeial requirements.
- Spearhead campus-wide harmonization efforts related to QA-VI activities across the Bedford, NH facility, driving operational excellence, standardization, and process efficiency.
- Partner with cross-functional leadership to optimize final product inspection, AQL strategies, management of qualification kits, defect library maintenance, and final product retain inspection programs.
- Provide expert quality oversight and sign-off for complex Quality System events, including major investigations, critical deviations, and high-impact CAPAs.
- Ensure robust compliance with cGMP regulations, internal policies, and evolving global regulatory expectations. Maintain audit-readiness across all QA-VI functions.
- Develop, monitor, evaluate, and present advanced Quality metrics and trends associated with QA-VI to site and corporate Senior Management.
- Proactively identify, assess, and escalate product quality risks and observations, driving risk-mitigation strategies to protect product safety and supply continuity.
- Serve as a primary SME and host for client audits and regulatory inspections (FDA, Health Authorities) concerning visual inspection, defect management, and product disposition.
- Ensure training programs are robust, dynamically updated, and that all staff maintain flawless qualification standing. Foster a culture of quality compliance, transparency, and data integrity.
- Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

- Ability to lead a site-based team
- Ability to manage other managers (direct reports)
- Honesty, integrity, respect and courtesy with all colleagues
- Creative with the ability to work with minimal supervision and balanced with independent thinking
- Resilient through operational and organizational change
- Ability to coach, train, and mentor others
- Cross functional staff, members of management, internal and external clients, members of the Quality organization
- Able to communicate effectively and tactfully
- Able to articulate and comprehend technical subject matter
- Able to comprehend, interpret, and articulate instructions set forth in local SOPs and regulatory guidance.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

- Requires the ability to lift, carry, push or pull light weights (up to 20 pounds)
- Frequent reading, writing, and verbal communication
- Able to translate ideas to actual concepts and processes
- Proven ability to manage multiple projects (duties) simultaneously
- Able to work in a highly complex environment with competing demands and priorities
- Ability to observe, identify potential issues, and resolve satisfactorily.
- Ability to provide hands on leadership, coaching, and coordination of needed actions with a focus on achieving goals and deliverables. Must be able to manage, plan and multi-task with minimal guidance.
- Support senior management as needed.
- Frequent travel between local Bedford, NH facilities.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

- Bachelor’s Degree in relevant scientific discipline. Minimum 10 years’ experience in GMP pharmaceutical or biotech industry, with 5+ years of experience in a Quality based role supporting clinical and/or commercial production, or equivalent combination of education and experience.
- Prior management experience in manufacturing, visual inspection, labeling/packaging, or Quality Assurance/Quality Control of sterile drug product is required.
- Strong understanding of regulatory visual inspection compendium and pharmacopeial standards, defect characterization.
- Strong technical writing skills to support investigations and risk assessments
- Exceptional organizational skills and attention to detail
- Ability to make risk-based decisions and resolve issues with minimal guidance
- Excellent interpersonal skills and the ability to communicate well orally and in writing
- Proficiency in MS Office including Word, and Excel
- Excellent verbal and written communication skills required

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.

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