Quality Assurance Manager

Life Science Logistics•Durham, NC

11d

About The Position

This position reports to and supports the Director of Quality and Compliance and manages direct reports. Ensure all LSL licensing is maintained for FDA, DEA, States and VAWD requirements for wholesaling and/or distribution as well as initially verify licenses for Clients and Client products as required for launch and annual verification. Manage change control of facilities, equipment and processes via paper and/or automated tracking system as required by cGMPs. Maintain change/revision history. Administer and maintain Quality System documents – master records, SOPs, WI including filing, scanning and archiving activities, etc. Manage periodic document review activities assisting CQCU and other Functional Owners to update content and confirm training requirements. Author or revise Standard Operating Procedures, Work Instructions, and training modules with Functional Owners alignment to control critical systems and assure conformance to FDA regulations, VAWD policies, and client-specific requirements. Report to the FDA annually during the designated time frame the information requested for a 3PL. Lead, Manage, and Participate in the internal audit program as well as develop and train new auditors for this program. Lead and/or help facilitate external audits to support the Director as needed. Support and assist all departments with research/investigation expertise to maintain compliance with business and regulatory needs. Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed. Participate in development of pedigree/Track and Trace methodology to support Commercial business growth. Collaborate with commercial partners to ensure seamless execution of Quality Systems for product and processes throughout development, product launches and commercialization phases. Lead change initiatives by identifying best approach for implementing strategic processes. Work with Directors for policy writing and implementation and all levels of personnel to achieve company quality standards and to ensure regulatory compliance. Leads the LSL Management Review process twice per year. Direct, mentor and train direct reports to support their career goals and LSL pipeline. This position does not have authority to sign contracts, LSL financial obligations, other than monthly expense reporting unless delegated by Director. Other duties as assigned.

Requirements

Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred).
Minimum of 5-7 years of experience in Quality in the medical device or pharmaceutical or other regulated industry.
A minimum of three (3) years supervisory experience – Required.
Effective time management skills
Impeccable verbal and written communication skills
Ability to conduct appropriate research as needed
Strong presentation skills
Strong analytical skills for safety and compliance
Attention to detail and organization
Critical thinking
Interest to work in a fast-paced environment
Navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL.
Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint.
Knowledge of applicable state and federal laws for warehousing and distribution of pharmaceutical and medical devices as well as the ability to interpret and apply rules and regulations including FDA, DEA, PDMA, DSCSA.
Intermediate public speaking and presentation skills.
Ability to track and present quality metrics/trends.
Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
Must be able to travel up to 20%.
Must have a valid driver’s license.
Work is light to medium in nature with frequent walking to perform assigned tasks.
Must be able to safely conduct occasional lifting of 20 to 50 lbs.
Activities occur within a typical office environment.
Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
Systems: Outlook, Excel, Word, PowerPoint, and MQ1 (Quality Management Software)

Nice To Haves

ASQ and/or ISO Auditor Certifications preferred.

Responsibilities

Ensure all LSL licensing is maintained for FDA, DEA, States and VAWD requirements for wholesaling and/or distribution as well as initially verify licenses for Clients and Client products as required for launch and annual verification.
Manage change control of facilities, equipment and processes via paper and/or automated tracking system as required by cGMPs.
Maintain change/revision history.
Administer and maintain Quality System documents – master records, SOPs, WI including filing, scanning and archiving activities, etc.
Manage periodic document review activities assisting CQCU and other Functional Owners to update content and confirm training requirements.
Author or revise Standard Operating Procedures, Work Instructions, and training modules with Functional Owners alignment to control critical systems and assure conformance to FDA regulations, VAWD policies, and client-specific requirements.
Report to the FDA annually during the designated time frame the information requested for a 3PL.
Lead, Manage, and Participate in the internal audit program as well as develop and train new auditors for this program.
Lead and/or help facilitate external audits to support the Director as needed.
Support and assist all departments with research/investigation expertise to maintain compliance with business and regulatory needs.
Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed.
Participate in development of pedigree/Track and Trace methodology to support Commercial business growth.
Collaborate with commercial partners to ensure seamless execution of Quality Systems for product and processes throughout development, product launches and commercialization phases.
Lead change initiatives by identifying best approach for implementing strategic processes.
Work with Directors for policy writing and implementation and all levels of personnel to achieve company quality standards and to ensure regulatory compliance.
Leads the LSL Management Review process twice per year.
Direct, mentor and train direct reports to support their career goals and LSL pipeline.
Other duties as assigned.