This is the upper tier of the middle management BioPharma Services Quality Assurance career track. Responsible for planning, development, organization, management, implementation, and maintenance of quality assurance systems and activities in the Biopharma and MedTech groups within the Pharma Services business unit.  

Incumbent demonstrates superior knowledge of regulatory requirements and works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined procedures and policies in selecting methods and techniques for obtaining solutions. 

Acts as advisor to company and becomes actively involved in problem resolution, as required. 

This professional can work in a hybrid capacity with a minimum requirement of 3 days onsite weekly.

Supervisory Responsibilities: Provides general or direct supervision including but not limited to:

• Interviewing, hiring, and training employees
• Planning, assigning, and directing work
• Administering performance reviews for direct reports in the Quality Assurance department
• Recommending salary actions & promotions
• Rewarding or disciplining employees
• Addressing complaints and resolving problems
• Developing and administer schedules
• Training and mentoring QA Staff

Essential Duties and Responsibilities:

• Maintain strong knowledge of and ensure compliance with regulatory requirements, to include, but not necessarily limited to, FDA & ICH GCP, GCLP and Quest Diagnostics policies
• Demonstrate and apply knowledge of applicable regulations and industry best practices. Apply knowledge of regulatory requirements on a daily basis including providing guidance on interpretation of, and compliance with, regulatory requirements (GCPs, CLIA), guidance, Good Clinical Practice (GCLP) guidelines and industry best practice.
• Provide guidance and expertise to staff, management, and work teams to address quality requirements and improvements.
• Communicate with staff verbally and in writing regarding regulatory interpretations.
• Provide guidance and expertise in the preparation of validation deliverables and execution of validation testing to Specialty Clinical Data Management, as needed.
• Oversee the Quality Management program for Pharma Services Biopharma and MedTech business including:
• Audits (internal and external)
• Non-conformances (NCEs), Corrective and Preventive Actions (CAPAs). Participate in investigations and help determine resolution
• Complaints etc.
• Document/record review (e.g. study plans and reports, training dossiers, etc.)
• Development and implementation of SOPs
• Requests for Information
• Investigate identified or reported concerns. Document findings and corrective actions, as applicable

• Coordinate intradepartmental activities.
• Direct the development and deployment of the internal GCP/GCLP inspection program for Quest Diagnostics testing facilities. Ensure consistency of inspection findings, timely reporting, and submission of credible corrective actions.
• Develop and prepare metrics/KPIs for the Quality Assurance Function. Prepare reports for management.
• Maintain and foster an open and communicative work environment.
• Uphold and promote Quest Diagnostics Core Values.
• Other duties may be assigned.

Required Work Experience:

• 8+ years’ experience in a QA role in a GCP environment with evidence of increasing responsibility to include internal auditing and Quality Management
• 4+ years prior experience in Pharma/BioTech, Contract Research Organization, Central Lab or in a health-care related field
• Experience with FDA and EU clinical trial regulations and including 21 CFR Part 11 Annex 11 computerized systems
• 3-5 years supervisory experience.

Preferred Work Experience

• Knowledge of, and experience with, Quality Management Systems applications
• Experience with Quality System Regulation (21 CFR 820) or ISO 13485 a plus
• Experience with managing complex programs with accountability for measured outcomes.

Physical and Mental Requirements

• Ability to sit for extended periods of time.
• May occasionally lift and/or move up to 10 pounds.
• Ability to use fine motor skills to operate office equipment
• Employee must frequently respond to text/email communications and may be required to be aware of ergonomic principles.
• Ability to receive and comprehend instructions verbally and/or in writing.

Technical /Job Specific Knowledge:

• Demonstrated knowledge of and experience with FDA GCP regulations and guidance (ICH E6, 21 CFR parts 50, 54, 56 and 312)
• Demonstrated knowledge of, and experience with, 21 CFR Part 11
• Demonstrated knowledge of, and experience with EU clinical trial regulations
• Demonstrated knowledge of, and experience with, Good Clinical Laboratory Practice guidance
• Experience with project management principles

Skills

• Excellent verbal and written communication skills.
• Exceptional interpersonal and influencing skills; ability to influence and create change.
• Strong organizational skills.
• Project management skills.
• Able to function in a matrix organization.
• Multi-tasking skills.

Education

• Bachelor's degree in a related scientific or technical discipline

Preferred Technical Training or Professional Licensing:

• Quality Assurance certification, e.g. RQAP-GCP, CQA
• Experience with, or certification in Lean or Six Sigma

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.