Senior Quality Assurance Manager

4 weeks ago

Cincinnati, Ohio, United States Johnson and Johnson Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Manager to lead our Preclinical Auditor team. The successful candidate will be responsible for ensuring the quality and integrity of our preclinical data and processes.

Key Responsibilities
  • Lead the planning, conduct, and reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities, and processes.
  • Manage complex or business-critical audits/issues in a support or lead role.
  • Support other auditors in planning, conducting, and reporting of audits.
  • Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
  • Support the CAPA process following the audit as needed.
  • Encourage and support others to properly manage and document the risk-based approach in audit planning and conduct.
  • Participate in regulatory inspections in a leadership role (e.g., host, backroom lead).
  • Identify training needs, support development, and provide training.
  • Independently advise and coach other auditors.
  • Supervise junior auditors/contractors and peer review audit reports.
  • Lead initiatives and actively participate in key projects across the organization or company.
  • Effectively influence key business partners to drive projects to completion.
  • Actively share business area and regulatory knowledge/expertise.
  • May act as a primary contact for internal and/or external stakeholders.
  • Independently provide consultation and advice to business partners on quality and compliance processes/procedures.
  • Interpret and apply regulations/policies to unique and/or complex issues.
Requirements
  • A minimum of a University/Bachelor's or equivalent degree is required, preferably in a Scientific or Technical field.
  • A minimum of eight to ten years of professional work experience in Quality Assurance, with a thorough understanding and experience with the application of Good Laboratory Practices (GLP).
  • Experience working in the Medical Device or Pharmaceutical industry.
  • Experience leading a cross-functional team.
  • Ability to identify and simplify complex issues, as well as apply a proactive, organized, and systemic approach to making decisions and resolving issues.
  • Ability to work in a team and demonstrate strong interpersonal, organizational, and oral/written communication skills.
  • Ability to work independently or autonomously with minimal guidance.
  • Experience in a R&D/Pre-Clinical QA, analytical, R&D laboratory, and/or animal facility environment.
Preferred Qualifications
  • Experience in medical devices or other highly regulated industry; military veteran leadership experience is an asset.
  • Broad-based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, laboratories, etc.).
  • Certification (e.g., Society of Quality Assurance, Registered Quality Professional - GLP - RQAP-GLP).
What We Offer
  • Up to 30% travel, domestic and international, required.
  • The anticipated base pay range for this position is $99,000 to $170,200.
  • In the California Bay Area - The anticipated base pay range for this position is $113,000 to $195,730.
  • The Company maintains highly competitive, performance-based compensation programs.
  • Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
  • The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year.
  • Bonuses are awarded at the Company's discretion on an individual basis.
  • Employees and/or eligible dependents may be eligible to participate in the following Company-sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
  • Employees are eligible for the following time off benefits:
    • Vacation - up to 120 hours per calendar year.
    • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
    • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year.

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