GLPGCP Quality Manager

GLP/GCP Quality Manager in Indianapolis IN

Work Schedule: Monday Friday 8-5 pm

Job Responsibilities:

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

Develops procedures as necessary to cover site GLP/GCP needs

Ensures recruitment and training of a competent and sufficient GLP/GCP QA workforce to meet business site needs

Accountable for budgetary oversight of the GLP/GCP QA team

Leads site communications with external Regulatory and Client compliance counterparts

Ensures the consistent implementation use and review of SOPs

Escalates issues to management in a timely manner and implements appropriate solutions including preventative actions

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

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

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

Leads functional process improvement initiatives to drive efficiencies and effectiveness of RC&QA processes

Interprets applicable quality regulations/standards and creates appropriate policies and procedures

Recruits trains coaches and develops individuals based on their development or business needs

Completes thorough timely and well-documented performance evaluations providing objective feedback

Ensures RC&QA management responsibilities as indicated in applicable controlled documents are followed

Supervise Direct report and performance management

Minimum Qualifications:

• Bachelors Degree in Life Science preferred (or equivalent Life Science experience)
• Experience may be substituted for education
• 8 years in a regulatory environment (experience in GLP/GCP roles)
• Minimum of 2 years supervisory experience
• Experience and regulatory expertise in industry quality systems/standards

Preferred Qualifications:

Ability to interpret applicable regulations/standards

Experience in leading process improvement initiatives

Ability to effectively communicate with and influence internal stakeholders

Ability to supervise resources in a single geographic location

Additional Job Standards: Labcorp has a GLP/GCP Quality Manager opportunity at the Laboratory in Indianapolis IN. The Quality Manager leads a GLP/GCP QA function and oversees all local aspects of functional operation and is accountable for maintaining client and regulatory satisfaction with all aspects of GLP/GCP compliance at the facility. Independent of Business Unit operations but maintains a reporting responsibility to the local Site Lead.

At Labcorp we are part of the journey to accelerate life-changing healthcare breakthroughs and improve the delivery of care for all. You will be inspired to discover develop new skills and pursue career building opportunities as we help solve some of todays biggest health challenges around the world. Together we embrace possibilities and change lives. We work around the clock and around the world to prove that quality science can solve global health issues and help save individual lives.

Are you knowledgeable about Regulations Clinical Laboratory Quality Management expereince needed and must have worked in a clinical Laboratory for 8 years with 2 years supervisory expereince. Do you love quality management problem-solving and being able to influence and communicate with other laboratory and quality team members Join an exceptional organization and strong Quality department as a GLP/GCP Quality Assurance Manager. Apply now!

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information pleaseclick here.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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