Vice President - Global Quality Assurance - Gcp

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as aVice President, Global Quality?

Job Description

Position Summary:

The VP, Global Quality is responsible for the leadership for the Quality group within Clinical Solutions including global planning, strategy and implementation of the Global Quality processes including oversight of audit programs, implementation of technology, and developing and implementing tactical plans throughout all Clinical Solutions globally to ensure compliance with regulations and to meet Precision's objectives.

Essential functions of the job include but are not limited to:

• Provide leadership and oversight of quality and compliance functions, ensuring that the Clinical Solutions operates in strict accordance with regulatory and corporate requirements
• Responsible for assuring the compliance of projects and programs with company SOPs, policies and all applicable worldwide regulations and guidelines (e.g., EU Directives, US FDA, MHRA, ICH and National regulations)
• Act as a strategic and proactive internal expert, to provide strategic compliance development advice and guidance for optimal conduct of clinical trials; demonstrating in-depth, working knowledge of SOPs, GCPs, and applicable regulations and guidelines
• Provide oversight of the generation and/or review key quality documents, including, but not limited to, Standard Operating Procedures (SOPs), Policies, Protocols, Reports, Specifications, Quality Investigations and Corrective Actions and Preventative Actions (CAPA)
• Plan and direct resources and activities of the quality and compliance functions globally
• Collaborate with cross-functional operational and quality staff in other Precision locations globally
• Establish a culture and mindset of ongoing compliance and continuous improvement in Precision's quality standards
• Support and guide the Quality Management Systems that support the quality functions in order to drive continual improvement and enhance customer satisfaction.
• Lead Quality responses for requests for information, business development proposals and attend business development meetings as required
• Ensure a technical liaison between Quality and all other functional management groups in terms of operational objectives with respect to quality
• Identify/lead and participate in process and improvement initiatives in relation to quality
• Serve as the management representative, providing updates to the company leadership regarding status of quality processes, compliance status and performance relating to quality
• Plan, promote and organize training activities related to product/service quality, Quality Assurance, and compliance
• Recruit, retain and develop first class staff responsible for providing Quality Assurance
• Coordinate with Learning & Development to ensure that all applicable, required training is provided
• Responsible for ensuring periodic management reviews of the quality system are conducted
• Maintain up-to-date knowledge of FDA, EU, MHRA & EMA regulations and applicable worldwide standards and requirements
• Maintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systems
• Work in conjunction with Vendor Management or similar groups to evaluate and validate vendors meet quality requirements
• Travel up to 30% including international
• Other duties as assigned

Qualifications:

Minimum Required:

• Bachelor's Degree in science, healthcare or related field of stud7
• 7 years of supervisory experience
• At least 20 years' experience working in clinical research with emphasis in Quality and Compliance

Other Required:

• Strong knowledge of the principles for a GCP Quality Management System, FDA Regulations, EU Directives and Regulations, ICH Guidelines and other relevant laws, regulations and guidance
• Strong executive presence and the demonstrated ability to influence cross-functional executive leaders
• Demonstrated ability to lead and manage a global function
• Experience auditing and interacting and relationship building with the public (regulators, vendors and clients)
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
• Able to travel both domestically and internationally including overnight stays
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Relevant Industry Certification
• Graduate, postgraduate degree, ideally in a scientific or healthcare discipline) or relevant clinical or business equivalent