Manager, Audit & CAPA

Posted 15 Days Ago
Be an Early Applicant
4 Locations
Remote
87K-124K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Manager, Audit & CAPA oversees a team of auditors, ensuring compliance with regulations and internal policies through effective audits. Responsibilities include generating assessment documentation, recommending process improvements based on data analysis, evaluating CAPA plans, and developing leadership presentation materials. The role involves continuous quality improvement within the organization.
Summary Generated by Built In

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

Primary Responsibilities:

  • Manages a team of auditors with responsibility for audit and oversight of Patient Services teams, including third party audits, client audits, and internal audit & oversight activities.
  • Implements an effective internal audit and oversight program. Performs audits to ensure alignment of business unit or location with the , internal policies and procedures, applicable regulations, and standards of practice.
  • Generates Assessment documentation including but not limited to: Plan, checklist, agenda, methodology, summation, and report(s).
  • Provides recommendations and data required for development of an annual risk-based assessment for the annual internal schedule.
  • Provides consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the operational business units.
  • Follows-up and provides data required for key performance metrics related to internal assessment performance, Corrective and Preventive Action (CAPA) program and continuous quality improvement.
  • Recommends organizational process improvement initiatives based on internal observations and CAPA data analysis.
  • Assists in the development and implementation of leadership presentation materials.
  • Follows-up and provides data required for data trending and analysis to monitor and report on the effectiveness of the Quality across Cencora.
  • Participates in quality training or awareness activities as directed
  • Evaluates the efficacy of completed CAPA plans implemented by the BU quality teams.
  • Ensures requested timelines are documented and met.
  • Performs related duties as assigned.

Experience and Educational Requirements:

  • Bachelor’s degree in healthcare or related field preferred, plus minimum 5 years related audit experience or formal investigation/problem-solving experience in life science operations, healthcare, or pharmacy industries, or an equivalent combination of education and experience.
  • Leadership experience preferred.
  • Prior project management and process development & implementation experience.
  • Current ISO 9001:2015, Quality auditing, QMS management certification preferred.

Minimum Skills, Knowledge, and Ability Requirements:

  • Strong understanding of compliance and regulatory concepts as they relate to specialty services, pharmacy, distribution, and medication support services.
  • Mathematical competence to calculate compliance rates. Ability to analyze data to create, charts, graphs, and table to represent results of audits/outcomes. Competency in formal problem-solving techniques.
  • Strong understanding of Six Sigma and/or Lean methodology preferred.
  • Advanced proficiency in MS Office software suite including Word, Excel, and PowerPoint.
  • Skilled in problem solving and critical analysis
  • Skilled in developing and delivering presentations.
  • Skilled in building organizational relationships.
  • Excellent communication and interpersonal skills

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. For details, visit https://www.virtualfairhub.com/cencora

Salary Range*

$86,500 - 123,860

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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Affiliated Companies:Affiliated Companies: Lash Group, LLC

The Company
HQ: Conshohocken, PA
41,000 Employees
On-site Workplace

What We Do

AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies and providers, we create unparalleled access, efficiency and reliability for human and animal health. Our 41,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #8 on the Fortune 500 with more than $200 billion in annual revenue.

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