GLP/GCP Quality Manager

Labcorp • Indianapolis, IN

3d

About The Position

Labcorp has a GLP/GCP Quality Manager opportunity at the Laboratory in Indianapolis, IN. This is a wonderful opportunity to join a strong Quality Team and Exceptional International Organization! 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? This Quality Manager will manage the overall quality and regulatory compliance for the Labs. Strong understanding of compliance with CLIA, CAP, ISO 15189, ISO13485, accreditations, and employee requirements. 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 today’s 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. Join an exceptional organization and strong Quality department as a GLP/GCP Quality Assurance Manager. Apply now! 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. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations (e.g., GCP, GLP) in the performance of their role.

Requirements

• Bachelor’s 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

Nice To Haves

• 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

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

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 Plan.
• Casual, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level