Vice President, Global Quality & Training

Vice President, Global Quality & Training

Vacancy expired!

Job Description

The Vice President of Quality & Trainingwill be responsible for strategic and functional leadership of the Global Quality Assurance and Training & Development functions, in support of service quality, continuous improvement and quality system compliance across ProPharma Group’s broad portfolio of services. This individual will help establish and maintain harmonized quality-related systems, processes, and governance mechanisms across the enterprise.

Essential Functions Include:

• Actively participate as a member of the Global Management Committee to sponsor enterprise-wide quality management best practices; facilitate Quality Management Reviews; escalate critical issues and risks; lead development and implementation of corporate Quality policies, procedures and practices.
• Support ongoing compliance processes to all relevant regulatory standards by facilitating the development, implementation, monitoring, and improvement of quality management systems and practices.
• Develop and harmonize corporate policies and procedures that provide an integrated approach among geographic locations and business units.
• Support business and operational efforts, including ensuring Quality representation in service development and improvement efforts.
• Manage and continuously improve the infrastructure required to perform the core activities of the Quality Management System, including complaints and deviations, Corrective & Preventative Actions (CAPAs), investigations, change control, validations, internal and external audit/inspections, supplier management program and customer inquiries/questionnaires.
• Provide critical inputs to and/or approvals of all design and change control efforts.
• Ensure that adequate training systems are in place and integrated across all sites. Ensure the provision of training and support to all relevant personnel at ProPharma Group to facilitate the delivery of high quality services to clients and promote professional development.
• Work with Practice Leadership to develop and align global training goals and objectives with the strategic plans of ProPharma Group annually.
• Lead the coordination, tracking and trending & drive closure of audit report responses, CAPAs, and deviations. Participate in development of corrective action plans and oversee the corrective action and preventative action (CAPA) program; Ensure closure and implementation in a timely manner.
• Manage and continuously improve the complaint and deviation handling process through maintenance of requirements, processes, and procedures, including requirements for root cause and impact analysis, and investigations as applicable.
• Maintain a state of continuous inspection readiness of the Quality Management System, including regular administration of internal audits to ensure compliance with relevant standards and regulations. Leads the process for (and participates as needed in the) hosting of third party audits.
• Maintain awareness and understand of emerging industry and regulatory trends.
• Design, compile, and analyze quality trends and issue QA & QC performance metrics reports to senior management.
• Build functional excellence within the Quality & Training organization through excellence in hiring, ongoing professional development & performance management, and organizational design.
• Personally engages with employees at all levels to educate on quality systems, results and issues to drive continuous improvement.

Qualifications

Qualified candidates must have:

• Minimum B.A/B.S. degree required, preferably in a life sciences discipline.
• 10+ years of experience in QA in the biopharmaceutical, healthcare or life sciences industry required.
• 8+ years of experience leading quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff.
• Life science service provider experience strongly preferred.
• Proficiency with standard business tools: word processing, Powerpoint, Excel; eQMS experience strongly preferred.
• <30%; limited travel (domestic and international) for Quality and Training system management, Global Management meetings and to support internal and external audits as needed.
• Demonstrated track record leading a critical corporate function; demonstrated success in leading through influence.
• Strong working knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Excellent understanding of and experience implementing Quality Management Systems in the context of a regulated life science environment; experience implementing and leading a QMS in a service environment highly preferred.
• Working knowledge of FDA and EMA pharmacovigilance requirements; experience in the provision of pharmacovigilance and/or medical information contact center services a plus.
• Working knowledge of data privacy regulations (GDPR, HIPPA, CCPA, etc.) highly preferred.
• Excellent oral and written communication skills with strong technical writing experience required.
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
• Demonstrated track record of cross-functional influence and engagement;
• Highly organized and detail oriented, with an analytical approach to problem solving and decision making.
• Strong working knowledge and application of the applicable quality and regulatory standards and track-record of successful customer audits and regulatory inspections.

Additional Information

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.