Quality Assurance Associate Director / Director
Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
- Provide guidance to technical areas within the laboratory in order to meet all regulatory and client requirements
- Direct the planning, hosting, coordinating of audits performed by sponsors and regulatory agencies.
- Follow-up on action items and CAPAs that arise from routine Client, Regulatory audits or other quality issues that arise to ensure appropriate and timely escalation, CAPAs and closure
- Schedule, coordinate, and document in-house QA / regulatory training program for technical and non-technical areas performing FDA / EMEA regulated work and other appropriate areas as directed by QA, Compliance, or business.
- Perform audits of Quality System including audits of corresponding documentation to ensure compliance.
- Lead Quality Assurance Team Meetings
- Direct the planning and execution activities of a team of direct reports as well as resourcing within the larger QA organization.
- Direct, lead, coordinate and participate in qualification audits of subcontractors, referral labs and or vendors as requested
- Manage and perform internal Pre Study, Study and Post Study audits in relation to Bio-Analytical / Bio Equivalence.
- Perform raw data audits to ensure accuracy and compliance to all applicable regulations and local SOPs.
- Determine if and assure that study deviations are appropriately documented and communicated
- Coordinate the assembly of the Bio-Analytical report and upon compliance sign off as required
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in a life sciences related discipline
- 10 years Quality Assurance Laboratory Management experience in pharmaceutical, technical, or related area
- California Medical Technologist License
- Strong knowledge of CAP, CLIA regulatory requirements
- Strong interpersonal and communication skills; must be confident interfacing and speaking with auditors, all levels of management, and senior level executives
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of quality assurance processes and procedures.
- Excellent problem solving, risk analysis and negotiation skills.
- Senior Lab Management experience in Quality Assurance
- Ability to influence and guide others at all levels of management.
- Working knowledge of GCP, ISO 15189, ISO 9001 requirements
- Demonstrated ability to lead and manage multiple responsibilities.
- Demonstrated ability to manage costs effectively through appropriate resource allocation.
- Demonstrated ability to articulate and define departmental needs and processes.
- Demonstrated ability to establish and maintain effective working relationships with coworkers, managers and clients
- Demonstrated knowledge of Microsoft office suite and database applications.
- Risk based decision making
- Excellent leadership and motivational skills
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