Senior Director- Quality Operations

Cencora; Columbus (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative company is seeking a Quality Systems Leader to drive compliance and quality assurance in the pharmaceutical industry. This role involves leading a dedicated team, ensuring adherence to regulatory standards, and fostering a culture of collaboration and excellence. With a focus on continuous improvement, you'll guide critical quality operations and investigations, making a significant impact on the health and safety of people and animals. Join this forward-thinking organization and contribute to creating healthier futures through your expertise and leadership.

Benefits

Health care

Wellness programs

Training and development opportunities

Qualifications

• 10+ years of experience in pharmaceutical manufacturing leadership.
• Expertise in cGMP documentation and FDA/DEA regulations.

Responsibilities

• Lead and mentor Quality Operations teams in compliance-critical roles.
• Ensure readiness for regulatory inspections and audits.

Skills

Leadership and management skills

Problem-solving skills

Root cause analysis

Proficiency in Microsoft Office

Organizational skills

Education

Bachelor's degree

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. All associates are responsible for observing safety rules and reporting hazardous or unsafe conditions immediately.

Key Responsibilities

1. Lead, train, and mentor the Quality Operations teams: Quality Investigations, CAPA, Supplier Quality, Production Quality, Warehouse Quality.
2. Develop leaders and foster a culture of collaboration focused on solutions.
3. Set departmental objectives aligned with site goals within the Quality Systems and Regulatory Affairs function.
4. Promote Quality Assurance principles to ensure the site is always prepared for regulatory inspections and audits.
5. Serve as the primary contact for DSCSA and serialization compliance requirements.
6. Represent AHP Quality on select corporate teams as needed.
7. Act as delegate of the VP, Quality Systems and Regulatory Affairs.
8. Oversee change control, validation, and operational activities from a Quality Assurance perspective.

Additional Responsibilities

1. Guide investigations and prioritize workload to meet regulatory and business objectives.
2. Ensure investigations comply with applicable requirements.
3. Oversee qualification of suppliers and service providers for compliance with AHP expectations, cGMP, and regulations.
4. Manage operations and warehouse quality to ensure compliance in packaging and distribution.
5. Oversee product disposition, including final approval or rejection of finished products, rework items, and materials under investigation.
6. Approve and maintain SOPs and Work Instructions for downstream processes.
7. Develop quarterly management reviews based on investigation trends.
8. Ensure all associates follow cGMP and safety procedures.
9. Develop and maintain cooperative working relationships.
10. Handle multiple tasks simultaneously.
11. Maintain good verbal and written communication skills.
12. Perform related duties as assigned.

Experience and Educational Requirements

A minimum of 10 years' experience leading and directing teams in the pharmaceutical/medical device manufacturing industry, including at least 5 years in leadership or management roles. A bachelor's degree or equivalent experience is required. Experience with pharmaceutical investigations, CAPA, deviation management, root cause analysis, cGMP documentation, and FDA/DEA regulations is essential.

Skills and Abilities

• Leadership and management skills.
• Strong problem-solving and root cause analysis skills.
• Proficiency in Microsoft Office applications.
• Organizational skills for prioritizing workload and handling multiple projects.
• Ability to work in a fast-paced environment and meet deadlines.

What Cencora Offers

We provide competitive compensation, benefits, and resources supporting an inclusive culture and personal growth, including health care, wellness programs, training, and development opportunities. For more details, visit https://www.virtualfairhub.com/cencora.

Equal Employment Opportunity

Cencora is committed to equal opportunity employment and prohibits discrimination and harassment. We provide reasonable accommodations for individuals with disabilities during the employment process. For accommodation requests, contact 888.692.2272 or [e-mail].