Quality Systems Program Mgr

CencoraJuncos, PR
34dOnsite

About The Position

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 Summary of Role: Develops, implements, and maintains an organization's quality management system (QMS), ensuring compliance with standards and regulations through policies, audits, and corrective actions (CAPA). They lead cross-functional teams, manage document control, oversee vendor quality, and use data analysis to drive continuous improvement, ensuring products/services consistently meet customer and company quality goals.

Requirements

  • Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
  • Engineering degree (prefertrable); Sciences
  • Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets .
  • Recommends new policies and procedures that affect program management.
  • May have budget accountability for one or more programs.
  • Program decisions are generally made only after consultation with higher level management.
  • Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem.
  • Problems typically impact multiple workstreams, departments or specialties .
  • Modifies programs management processes to improve program.
  • Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team.
  • Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
  • Direct involvement in daily tasks necessary for successful program execution.
  • Not directly responsible for hire or fire decisions and people management.

Nice To Haves

  • Hands on Experience on Projects/Scheduling for Medical Device manufacturing
  • Excellent Negotiating and Communication Skills
  • Risk Management/Critical Thinking
  • Conflict Resolution skills
  • Knowledge in Medical Devices regulations

Responsibilities

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Is accountable for overall program process, performance, and customer satisfaction.

Benefits

  • 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.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Number of Employees

5,001-10,000 employees

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