The Quality and Regulatory Affairs Manager position is responsible for the management, execution and development of all activities related to LSL’s Quality Management System assuring products and services are compliant, safe and reliable across all LifeScience Logistics (LSL) facilities. Key responsibilities include the oversight of the document management system (electronic, hybrid and paper), internal and external audit programs, and compliance with all FDA, DEA, ISO, VAWD and State Board of Pharmacy licensing requirements. This position is responsible for verification of new and annual Client’s FDA manufacturing licensing and product approval for LSL to receive, store and distribute Client product. This position reports to and supports the Director of QARA and manages 4 direct reports.
Quality and Regulatory Affairs Manager
- Dallas, TX
- Full Time
- 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 QARA 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.
QUALIFICATIONS AND JOB SPECIFICATIONS:
- 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.
- ASQ and/or ISO Auditor Certifications preferred.
- Demonstration of the following: 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
ADDITIONAL EMPLOYMENT REQUIREMENTS:
- 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%., and must have a valid driver’s license.
PHYSICAL/MENTAL/VISUAL DEMANDS/WORKING CONDITIONS/EQUIPMENT OPERATED
- 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.
- 10% of time is spent in a warehouse setting.
- Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
- Systems: Outlook, Excel, Word, PowerPoint, and MQ1 (Quality Management Software)
- LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation or gender identity.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.