QA Manager, Operations (QA-ISI)

Primary Duties and Responsibilities:

• Manage the quality investigations (e.g. Event, CAPA) process for the assigned programs / departments by ensuring that nonconformances and other reportable events are documented, investigated for root cause, corrective actions are assigned, closed out within the eQMS, and all related data reviewed for adverse trends;
• Manage the controlled documents (Policies, SOPs, WIs and Forms) request, review and issuance workflow by actively collaborating with each program/department leadership to ensure the controlled documents are generated and finalized in a timely manner.
• Manage the Quality Systems team by providing leadership and direction. Ensure objectives are assigned and progressed, and that associates are receiving adequate feedback and support as necessary.
• Manage and provide performance feedback for direct reports.
• Conduct periodic Quality Management Review meetings with program/department leadership to review key quality metrics, discuss trends/issues and coordinate quality improvement initiatives.
• Implement continual process improvements related to assigned program/departmental processes and/or internal processes as required.
• Implement Quality Assurance procedures as per internal requirements and/or client contractual requirements.
• Understand program/project roadmap and key milestones regarding criticality, downstream impact if dates are missed and determine alternative/mitigating actions.
• Provide timely, concise communications to functional and executive leadership regarding project status and pending issues.
• Build consensus among multiple functional and technical leads relative to project audit scope, task execution, staffing and issue resolution.
• Recommend corrective actions to program/department leadership when project deliverables deviate from the work plan with the assistance of team members.
• Interact with project sponsors, stakeholders, vendors, and various project members to ensure that specified business needs are met. Assist in the post-implementation analysis to ensure that requirements are fulfilled.
• Serve as a resource to internal stakeholders for the interpretation and application of regulations and applicable guidelines.
• Assist with hosting and coordinating external audits by clients or regulatory agencies, including coordination of responses and corrective actions with the relevant departments to ensure timely resolution of observations and issuance of responses.
• Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required.
• Understand and apply company Confidentiality and Privacy Agreements
• May also be assigned other duties / tasks to support additional QA areas by the Director, Quality Assurance – ISI.
• Travels up to 20% of the time.

Experience and Educational Requirements:

• Bachelor of Science Degree in a scientific, healthcare or pharmaceutical field, or equivalent.
• Minimum of 10 years’ experience in the healthcare, pharmaceutical or biotechnology industry (or similar), preferably in a quality assurance or quality control function.
• Minimum of 5 years’ experience in hosting external audits and management of multiple projects (planning, implementation, management and monitoring) including budget, resource planning, Key Performance Indicators, etc.;
• Industry certification in Quality or Clinical Research (e.g., CQA, RQAP-GxP, CCRC, CCRA, CCRP, etc.) is an asset.
• Adaptability to change and to learn new skills as required; and
• Bilingualism, French/English is an asset.

Minimum Skills, Knowledge and Ability Requirements:

• Strong knowledge in quality assurance principles and quality management, including design and operation of effective quality and regulatory compliance programs;
• Advanced knowledge of root cause analysis and CAPA investigations;
• Ability to develop and implement customized Quality Assurance procedures specified by internal/external industry specification;
• Advanced analytical, conceptual and problem solving skills to evaluate business; problems and apply knowledge to identify appropriate solutions;
• Well-developed leadership, analytical, and decision making skills, with an aptitude to appropriately apply scientific, regulatory and administrative knowledge to accomplish department and company goals.
• Superior skills in planning, organization and managing multiple priorities yet being flexible, adaptable and able to respond to changing needs.
• Proven conflict management skills with the ability to provide leadership to others in response to situations and to escalate more critical decisions when relevant.
• Excellent verbal and written communication skills, work well in an interdependent team environment, and promote positive, respectful professional relationships. Proficient in writing reports containing technical information;
• Effective presentation skills and experienced in the development of training courses and materials.
• Proven ability to organize time, set priorities and multi-task in order to meet various competing work deadlines;
• Strong attention to details and data analysis skills;
• Ability to work independently and in a team environment;
• Strong proficiency in Microsoft applications (Word, Excel, PowerPoint, , Outlook), Adobe Acrobat.

What Cencora offers

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.

Equal Employment Opportunity

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

Accessibility Policy

Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

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