QA Manager, GLP Medical Devices
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
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
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
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.