Job Details

Under the general direction of the Vice President, Quality Systems and Regulatory Affairs, responsible for developing, revising, and maintaining Quality Assurance systems to ensure compliance with cGMP, FDA/DEA regulations, and corporate policies.
This position is compliance-critical, with responsibilities including ensuring continual and proper compliance with all division corporate and government regulatory requirements. It is the associate's responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

• Directs, leads, trains, and mentors the broader Quality Operations functions: Quality Investigations, CAPA, Supplier Quality, Production Quality, Warehouse Quality.
• Actively develops leaders and fosters a culture of collaboration focused on solutions.
• Sets departmental objectives aligned with site goals within the Quality Systems and Regulatory Affairs function.
• Promotes Quality Assurance principles throughout the facility to ensure readiness for regulatory inspections and audits.
• Serves as the primary contact for DSCSA and serialization compliance requirements.
• Represents AHP Quality on select corporate teams, as needed.
• Functions as a delegate of the VP, Quality Systems and Regulatory Affairs.
• Oversees change control, validation, and operational activities from a Quality Assurance perspective.

• Guides team members in Quality Investigations and CAPA, prioritizing workload to meet regulatory and business objectives.
• Ensures investigations are conducted within applicable requirements.
• Oversees qualification of suppliers and service providers to ensure compliance with AHP expectations, cGMP, and regulations.
• Directs broader Quality team to ensure packaging and distribution compliance.
• Oversees product disposition, including final approval/rejection of finished products, rework items, and investigation materials.
• Approves and maintains departmental SOPs and Work Instructions.
• Prepares quarterly management reviews on investigation trends.
• Ensures all associates follow cGMP and safety procedures.
• Develops and maintains cooperative working relationships.
• Handles multiple tasks simultaneously.
• Communicates effectively in verbal and written forms.
• Performs related duties as assigned.

Experience and Educational Requirements:

Minimum of 10 years leading and directing teams in pharmaceutical/medical device manufacturing.

At least 5 years of management experience.

Bachelor's degree or equivalent experience and education.

Experience with Pharmaceutical Investigations, CAPA, deviation management, root cause analysis, cGMP documentation, and Quality Assurance.

Knowledge of FDA and DEA regulations is required.

Skills, Knowledge, and Abilities:

• Leadership and management skills.
• Strong problem-solving and root cause analysis skills.
• Proficiency in Microsoft Office (Word, Excel).
• Excellent organizational skills for prioritizing workload and responsibilities.
• Ability to work in a fast-paced environment and meet deadlines.

What Cencora Offers

We provide compensation, benefits, and resources that foster an inclusive culture and support our team members' purposeful lives. Benefits include medical, dental, vision, wellness programs, support for working families, training, professional development, mentorship, employee resource groups, volunteer activities, and more. For details, visit

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any protected class. We prohibit harassment and ensure all employment practices are non-discriminatory. We provide reasonable accommodations for individuals with disabilities during the employment process. To request an accommodation, contact 888.###.#### or email ...@cencora.com.

Affiliated Companies

Affiliated Companies: Amerisource Health Services, LLC