Quality Manager- CAPA and Investigations

Cencora, Inc.; Ontario; On-site; CAD 80,000 - 100,000; Full time

Job summary

Cencora, a leading company in the pharmaceutical industry, is seeking a Quality Manager for CAPA and Investigations. This role involves managing teams, ensuring compliance with regulatory standards, and implementing process improvements. The ideal candidate will have extensive experience in quality assurance and team leadership, contributing to the company's mission of creating healthier futures.

Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Wellness Programs

Professional Development

Qualifications

• Minimum of 3 years' experience leading and directing teams.
• At least four years of relevant pharmaceutical industry experience.

Responsibilities

• Manage Quality Investigation and Supplier Quality teams.
• Oversee compliance with cGMP and safety procedures.
• Implement process improvements through data analysis.

Skills

Leadership

Problem Solving

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!

The Quality Manager - CAPA and Investigations is responsible for managing the Quality Investigation team, the Supplier Quality team, and their daily activities, including internal / external investigations, CAPA, deviation management, supplier quality, and other assigned activities. The role involves overseeing processes for investigations, disposition of packaging components, BPL drug products, contract packaging components, finished goods, deviation processes, CAPA, risk management, and data analysis for tracking and trending. Additionally, the manager oversees supplier quality processes related to investigations, audits, and quality agreements.

This position is compliance-critical, requiring adherence to all division, corporate, and government regulatory requirements. Safety rules must be observed at all times, and any hazardous or unsafe conditions should be reported immediately.

• Lead, train, and mentor the Quality Investigation and Supplier Quality teams.
• Prioritize daily tasks and workload for the teams.
• Implement process improvements through data analysis to enhance efficiency while maintaining quality.
• Guide inspection, release, rejection, or quarantine of packaging materials and finished drug products.
• Support internal audits and external supplier audits.
• Develop quarterly management review reports on investigation trends.
• Conduct performance reviews for direct reports.
• Maintain departmental SOPs and work instructions to streamline processes.
• Respond to CAPA and deviation queries from various departments.
• Ensure compliance with cGMP and safety procedures.
• Develop and maintain cooperative working relationships.
• Communicate effectively in verbal and written forms.
• Perform other duties as assigned.

Experience and Education

Minimum of 3 years' experience leading and directing teams required. A bachelor’s degree or equivalent experience, plus at least four years of relevant pharmaceutical industry experience, is necessary. Experience with pharmaceutical investigations, CAPA, deviation management, root cause analysis, cGMP documentation, and quality assurance is essential. Knowledge of FDA regulations is required. Experience with Document Control Systems and inventory management systems is also required.

Skills and Abilities

• Leadership and management skills
• Strong problem-solving and root cause analysis skills
• Proficiency in Microsoft Office (Word, Excel)
• Organizational skills for prioritizing workload
• Ability to manage multiple projects
• Capability to work in a fast-paced environment and meet deadlines

What Cencora Offers

We provide comprehensive compensation, benefits, and resources fostering an inclusive culture and supporting our team members' purpose-driven 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 .

Cencora is committed to providing equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or other protected classes. We ensure non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers. Reasonable accommodations are available for individuals with disabilities during the employment process. For accommodation requests, contact 888.692.2272 or [emailprotected] . Messages unrelated to accommodation requests will not be responded to.

Affiliated Companies

Affiliated Companies : Amerisource Health Services, LLC