Sr. Manager, Quality Systems & Compliance

AbbottPleasanton, CA
Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Manages subordinate QA management and experienced QA specialist employees who exercise significant latitude and independence. Often heads one or more departments. Establish operating policies and procedures that affect departments and subordinate sections and work units. Interprets companywide policies and procedures. Develops budgets, schedules and performance standards. Assignments are objective oriented. Work is reviewed in terms of meeting the organization's objectives and timelines.

Requirements

  • Bachelor’s degree in engineering or Technical Field or an equivalent combination of education and work experience.
  • 7-10 years of experience in function or related field.
  • 4-6 years of direct supervisor experience.
  • Must have demonstrated solid knowledge and experience in discipline.
  • Leadership experience is required.
  • Considered a Subject Matter Expert and key contributor to initiatives.
  • Leader and key contributor to initiatives and advancement of the Quality organization.
  • Emerging Leader.
  • Demonstrates strong leadership competencies.
  • Makes decisions and charts course through careful evaluation of risks and benefits with limited information in conjunction with Director.
  • Builds/drives relationships and teamwork within team and across functions with professional demeanor.

Nice To Haves

  • Master’s Degree

Responsibilities

  • Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, regulatory requirements, scheduling requirements and or contractual clarifications.
  • Leads briefings and technical meetings for internal and external representatives.
  • Liaise with customers and suppliers.
  • Responsible for managing multiple quality system elements/functions for the Business Unit.
  • Implements the quality plan in accordance with the quality objectives/goals and maintains the effectiveness of the quality system.
  • Determines staffing and other resource requirements needed to achieve business goals and compliance requirements.
  • Resolves project team issues.
  • Leads complex process improvement teams and/or initiatives.
  • Responsible for the development and management of staff.
  • Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.
  • Develop quality goals based on the business strategies, collaborate with other business units on common goals and drives for results.
  • Additional responsibilities may include: Establish and implement necessary communication strategy for the improvement and awareness of quality issues.
  • Responsible for department financials and for managing cost improvements.
  • Responsible for the Quality Systems and Regulatory Compliance function within one discipline or multiple disciplines for the Business Unit.
  • Balance complex resource needs across QA functions.
  • Decision making that has an extended impact on work processes and outcomes, that could cause substantial expenditure of additional time, human resources, and funds and jeopardize future business activity

Benefits

  • free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
  • An excellent retirement savings plan with a high employer contribution
  • Tuition reimbursement
  • the Freedom 2 Save student debt program
  • FreeU education benefit
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