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Job Details


Labcorp (Drug Development)

QA Manager, GLP Medical Devices

Business and Financial Operations

All

Yearly

Full Time

No

San Carlos, California, United States

Do you have medical device safety testing experience? Do you have experience as a Lead Auditor with GLP? If so, we want you to join our Global QA team as the QA Manager GLP Medical Devices in San Carlos, CA.

Labcorp Drug Development’s work in developing new pharmaceutical and medical device solutions have an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

We are offering a sign-on bonus of $5,000 (paid after 60 days of employment)

Position Overview

In this role, you will lead a GLP QA function at a Drug Development facility. In this capacity, you will oversee all local aspects of functional operation and are accountable for maintaining client and regulatory satisfaction with all aspects of GLP compliance at the facility. Also, you will oversee and perform quality assurance functions for nonclinical laboratory medical device safety studies, following US FDA GLPs 21 CFR Part 58, including, but not limited to:

  • Plans and executes the necessary QA inspection programs to maintain local GLP compliance

  • Ensures recruitment, training, coaching, development and management of a competent GLP QA workforce to meet business site needs

  • Accountable for budgetary oversight of the GLP QA team

  • Ensures the consistent implementation, use and review of SOPs

  • Negotiates with functional and operational internal stakeholders to improve quality and increase efficiencies

  • Analyzes and interprets data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes

  • Supports functional process improvement initiatives to drive efficiencies and effectiveness of business processes.

  • Leads and effectively manages constructive crucial interactions with clients or regulatory agencies

  • Interprets applicable quality regulations/standards and create appropriate policies and procedures

  • Ensures Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed

Education/Qualifications
  • A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry, Biology, or biotechnology related discipline

  • Postgraduate degree (MSC or equivalent) in science or management related discipline is preferable

  • Experience may be substituted for education

Experience
  • 8 years’ in regulatory environment (experience in GXP roles)

  • Experience & regulatory expertise of industry quality systems/standards

  • Ability to interpret applicable regulations/standards

  • Experience in leading process improvement initiatives

  • Ability to communicate and negotiate internal stakeholders effectively

  • Ability to supervise resources in a single geographic location

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Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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