Quality Manager- CAPA and Investigations

The Quality Manager- CAPA and Investigations is responsible for the management of the Quality Investigation team, the Supplier Quality team and their daily activities, which include Internal/External investigation, CAPA and Deviation management, Supplier quality and other activities as assigned. The Quality Manager, will manage the processes for Internal and External investigation, disposition of packaging components, BPL drug product, and contract packaging components; finished goods. The Quality Manager will also oversee the deviation process, CAPA and Risk Management activities and conduct data analysis for tracking and trending purposes. In addition the Quality Manager will oversee the supplier quality process as it pertains to investigations, auditing and quality agreements development.

This job position is compliance critical and responsibilities include 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 Quality Investigation and Supplier Quality teams.
• Provides direction of daily tasks and prioritizes workload of team.
• Utilizes process improvements by collecting and analyzing data to gain efficiencies while maintaining quality of work.
• Provide guidance to inspect, release, or reject, quarantined packaging material and or finished drug products.
• Provides guidance to internal audit team and external audits of suppliers.
• Responsible for developing quarterly management reviews on investigation trending.
• Conducts performance reviews for direct reports.
• Develops and maintains departmental SOPs and Work Instructions in order to streamline processes.
• Responds to investigation CAPA and deviation queries from various functional areas
• Assures all associates follow cGMP and safety procedures
• Ability to develop and maintain cooperative working relationships
• Ability to handle a variety of tasks simultaneously
• Good verbal and written communication skills
• Performs related duties as assigned

Skills and Abilities:

• Ability to lead and manage individuals
• Strong problem-solving and root cause analysis skills are required
• Proficient in Microsoft Office applications (Word, Excel)
• Possess strong organizational skills for prioritizing workload and responsibilities
• Ability to handle multiple projects
• Must be able to work in a fast-paced environment and deliver projects and requests on time with respect to established timelines

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned