Title: Manager, Quality Management, CAPA
Location: Dallas, TX; Atlanta, GA; Richmond, VA; Columbus, OH
Hybrid/Onsite/Remote: HYBRID
Job Description
McKesson seeks a seasoned leader with a solutions-oriented focus to serve as a Manager, Quality Management, CAPA for the enterprise-level Quality function, reporting to the Director, Enterprise Quality Management. This new role provides CAPA technical expertise, problem solving, e-QMS workflow design and optimization, lead the CAPA community of practice, training and education in alignment with industry best practices for a wide variety of businesses within the McKesson enterprise, including departments within distribution centers, 3PL, and/or Pharmacies. The Manager, Quality Management, CAPA will act as subject matter expert (SME) and deliver guidance, support and oversight to quality functional areas including but not limited to Incident management process, Deviations and CAPA.
Job Location: **The location of the role is hybrid with required travel to be onsite at other McKesson facilities is required. **
Scope of Responsibilities:
Responsibilities for the Manager, Quality Management, CAPA include, but are not limited to:
- Collaborate effectively with the Director of Quality Management and CAPA, as well as the entire Enterprise Quality Management team.
- Collaborate with quality and functional teams across business units to develop and propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
- Ensure that quality and operational requirements are defined, implemented, and monitored according to business quality objectives. The Manager will implement process controls to reduce variation and create process consistency, with the focus on CAPA.
- Lead and facilitate the creation and implementation of strategies related to Continuous Improvement, Root Cause Analysis (RCA), Process Failure Modes Effect Analysis (PFMEA), Failure Modes Effect Analysis (FMEA). Ensure these strategies are aligned with the organization goals and objectives and implement the appropriate metrics to track progress and ensure success.
- Assist in the development and maintaining of enterprise policies and procedures, ensuring that they are up-to-date and aligned with industry best practices.
- Participate in the evaluation and prioritization of risks facing the organization and work with the Business Quality Leaders to develop mitigation strategies.
- Promote and support a comprehensive culture of quality throughout the organization and departments. Foster collaboration with cross-functional teams to drive compliance, product quality and operational excellence.
- Develop and champion a continuous improvement Total Quality Management culture which utilizes Lean, data analytics and Six Sigma methodologies to drive decision making and solve problems. Drive systemic thinking across the organization.
- Working with the business and enterprise team, set up metrics and targets based on data analysis; continuously monitor operation performance, encourage leaders and team members to actively contribute ideas, and recommendations on how to address and enhance service levels.
- Assist in the development and implementation of special projects that address CAPA. This may include developing and delivering education to employees across the organization.
- Assist in the development, enhancement, and implementation of global standard investigative protocols and guidelines to create more collaboration and consistency across functional teams.
- Drive organization change and meet the needs of the changing business, using technical expertise, skills, knowledge, and experience and cross-training, as required, to ensure quality goals and core business objectives are achieved.
- Stay up to date on emerging risk and trends in the industry and provide guidance and recommendation to senior leadership on how to address them.
Candidate Profile
- In-depth knowledge of departments within manufacturing, distribution center, 3PL, and/or Pharmacies function and their interdependencies (overall end to end supply chain).
- Proven experience in developing solutions that requires a multi-disciplinary approach.
- Strong critical thinking skills with the ability to understand and analyze complex issues, see the “big picture” and propose practical and effective solutions.
- Ability to investigate issues to root cause and develop safeguards from event(s) occurring again.
- Excellent written and verbal communication skills; ability to communicate effectively with internal stakeholder’s, colleagues, and external Regulators.
- Passionate about continuous improvement with has a track record of successfully leading and motivating teams to achieve success.
- Positive change leader, skilled in motivating and inspiring others to achieve common goals. people skills.
- Understanding of lean and six sigma methodologies is preferred.
- Ability to effectively communicate level of risk, priority, or impact to the business in a clear and concise manner.
Minimum Requirements
- 5+ years of experience in life sciences or healthcare industry.
- Bachelor’s degree in Core Sciences, Engineering or Business Administration.
- Experience in working within an operation site environment such as manufacturing, distribution, or pharmacy leading and managing an hourly workforce either in Quality or Operations.
- People management experience of hourly employees on a shop floor (i.e., distribution center, production floor environment).
- Must be solutions-oriented person individual with a hands-on approach, willing to roll up your sleeves and work alongside the businesses to resolve and fix issues.
- Able to operate effectively in a multiple business/highly matrix environment and inspire the trust, confidence, and respect of peers and other senior leaders.
- Possess strong interpersonal and teamwork skills – including oral and written communications, relationship building, collaboration, influencing, negotiation and conflict mediation, across a broad range of levels in the organization.
- Familiarity with regulatory requirements such as FDA/ISO/OSHA/BOP.
- Experience electronic quality management systems software and workflows (TrackWise, Master Control, Veeva, etc.)
Must be authorized to work in the US. Sponsorship is not available for this position.
