Quality Manager- CAPA and Investigations

Cencora, Inc.; Ontario; On-site; CAD 70,000 - 110,000; Full time

Job summary

An innovative company dedicated to creating healthier futures is seeking a Quality Manager for CAPA and Investigations. This pivotal role involves leading a dynamic team responsible for quality investigations, CAPA, and supplier quality processes. You will oversee compliance with regulatory requirements while implementing process improvements to enhance efficiency. Join a mission-driven organization that values your contributions and offers comprehensive benefits, professional development, and a supportive work environment. If you're passionate about quality assurance in the pharmaceutical industry, this is the opportunity for you.

Benefits

Medical benefits

Dental benefits

Vision benefits

Wellness programs

Support for working families

Professional development

Mentorship programs

Employee resource groups

Volunteer activities

Qualifications

• Minimum 3 years' experience leading teams in a pharmaceutical setting.
• Knowledge of FDA regulations and cGMP documentation required.

Responsibilities

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

Skills

Leadership and management skills

Problem-solving and root cause analysis

Proficiency in Microsoft Office

Organizational skills

Project management

Education

Bachelor’s degree in relevant field

4+ years in pharmaceutical industry

Tools

Document Control Systems

Inventory management systems

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

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.
• Handle multiple tasks simultaneously.
• 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.

Equal Employment Opportunity

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 [e-mail]. Messages unrelated to accommodation requests will not be responded to.

Affiliated Companies

Affiliated Companies: Amerisource Health Services, LLC