Senior Director- Quality Operations

Cencora, Inc.; Columbus (OH); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative company is seeking a Quality Assurance leader to ensure compliance with regulatory standards in a fast-paced environment. This role involves directing Quality Operations, fostering a collaborative culture, and overseeing critical compliance activities. The ideal candidate will have extensive experience in pharmaceutical manufacturing, strong leadership skills, and a commitment to quality excellence. Join a team dedicated to improving lives and making a meaningful impact in the health sector. This is a fantastic opportunity to advance your career in a supportive and inclusive workplace.

Benefits

Medical insurance

Dental insurance

Vision insurance

Wellness programs

Professional development

Mentorship

Employee resource groups

Volunteer activities

Qualifications

• 10+ years in pharmaceutical/medical device manufacturing leadership.
• 5+ years of management experience required.

Responsibilities

• Develop and maintain Quality Assurance systems for compliance.
• Lead and mentor Quality Operations functions.

Skills

Leadership and management skills

Problem-solving skills

Root cause analysis

Proficiency in Microsoft Office

Organizational skills

Education

Bachelor’s degree or equivalent experience

Tools

Microsoft Office

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

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 https://www.virtualfairhub.com/cencora.

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 888.692.2272 or email [e-mail].

Affiliated Companies

Affiliated Companies: Amerisource Health Services, LLC