QA Manager - Client Lead

QA Manager- Client Lead

Labcorp has a QA Manager - Client Lead position in Indianapolis, IN. 

Is Quality your passion?  Do you have Quality Manager experience in the world of diagnostics?  Do you have 8 years' experience in a Regulated environment (experience in GXP roles) and strong communication and negotiation skills?

This Manager, as an independent contributor, they will work with designated study management and QA teams in executing quality assurance programs for consistent and effective management of Quality Issues and CAPAs.  Assists senior management in the development of robust quality systems and drives improvement in the RC&QA organization.

This is an Individual contributor role, Client Facing role!  This QA Manager will need to have Strong organizational skills, planning, and timely delivery and execution on any actions needed.  The Manager will need to have strong influencing, negotiation skillset for both internal (Project Mgt and Operational Area SMEs) and external Client-facing engagements.  Must have Persuasive communication skillset, especially with Client QA counterparts.

This is NOT a remote role but has the potential of being hybrid following training.

Essential Job Duties:

♦ Oversees timely completion of CAPAs and QIs in QMS

♦ Supports internal and external teams in creation of CAPAs

♦ Supports in pulling metric data, trending and tracking of QIs for client metrics and prepare presentations, conveying confidence with a partnership in deriving solutions to address quality needs

♦ Leads scoping and execution of RC&QA improvement initiatives and supports execution of global improvement initiatives

♦ Ensure the consistent implementation, use and review of SOPs

♦ Escalate issues to management in a timely manner, offer potential solutions through internal stakeholder collaboration as part of escalation, wherever possible and implementing appropriate solutions including preventative actions

♦ Negotiate with functional and operational internal & external client (project and QA client) stakeholders to improve quality and increase efficiencies

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

♦ Lead and effectively manage constructive crucial interactions with clients or regulatory agencies

♦ Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes

♦ Interpret applicable quality regulations/standards and create appropriate policies and procedures

♦ Lead interactions with clients or regulatory agencies

♦ Recruit, training, coaching, and mentoring internal stakeholders, especially Global Study Mgt partners and QA peers and develop individuals based on their development or business needs

♦ Complete thorough, timely and well documented performance evaluations providing objective feedback to the individuals

♦ Ensure Regulatory Compliance and Quality Assurance (RC&QA) management

responsibilities, as indicated in applicable controlled documents, are followed

Minimum Required:

♦ 8 years in regulatory environment (experience in GXP roles)

♦ A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)- Experience may be substituted for education.

♦ 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 work with resources in a single geographic location

All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. 

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. For more detailed information, please click here. 

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