Your new company

Your new role

What you'll need to succeed

• Provide direct management of assigned QA&C personnel, including performance management, career development and growth, training, and employee relations
• Provide internal customer (i.e., functional area) consultation, guidance, and risk assessment regarding issues, and interpretation of regulations and standards
• Represent the Quality Assurance and Compliance organization as a single point of contact and provide technical resource guidance for assigned projects/clinical trials
• Review Deviation documentation, root cause analysis results, and proposed CAPAs, and provide guidance and direction on appropriate actions and documentation
• Identify and assess GCP compliance risks, work with functional areas and other Quality Assurance and Compliance personnel to develop and implement risk mitigation
• Review functional area SOP content for compliance and business issues
• Assist with assessing hiring needs, interviews, and hires to align with the needs of the department
• Coordinate and oversee training events related to QA & Compliance
• Direct the client audit management function to ensure that client audits are efficiently managed and responses to client audit findings are completed in a timely fashion
• Direct the internal and vendor audit function to ensure that the operations of all functional groups follow corporate SOPs and applicable regulations and guidelines, and that external parties (i.e., vendors) follow applicable regulations and guidelines
• Lead the tracking of various types of quality data and reports to identify gaps and report of trends to support process improvement
• Author controlled documents and actively suggest improvements to existing controlled documents
• Provide training, guidance, and support to the organization on the Quality Management System
• Review selected regulatory/clinical/technical documents, i.e., validation documentation, for quality and compliance with applicable regulations/guidelines/industry expectations
• Serves as a leader, point of mentorship, and point of escalation for assigned staff and more junior members of the QA&C team
• Provide support to other tasks and initiatives as directed by the global head of QA&C
• Contribute to the continuous process improvement within the department; bring efficiencies and best practices to the organization through the design and implementation of new or updated procedures or workflows
• Lead by example and models core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development

• Bachelor’s degree required; science-related degree preferred. 10+ years of GCP experience in an FDA regulated environment required, to include a minimum 5 years in the sponsor and/or Full Service CRO industry preferred, and at least 5 years of supervisory experience required.
• Strong working knowledge of GCP regulations, ICH and FDA guidance documents, industry standards, and best practices required.
• Demonstrate ability to lead by example and demonstrated skill for technical and supervisory leadership of staff required.
• Solid understanding of global clinical research regulations, including but not limited to ICH E6(R2) Good Clinical Practice and 21 CFR Part11, required.
• Knowledgeable in FDA regulated Quality Systems, including document control, CAPA, and training required.
• Experience with implementation and management of GxP related computer systems required.
• Effective written and oral communication skills, ability to express information and guidance orally and in writing required.
• Proficiency in Microsoft Project, Word, Excel, and PowerPoint required.
• Strong organizational skills with a high level of attention to detail, and the ability to coordinate between internal and external stakeholders required.
• Ability to work independently, take initiative, set priorities, and see projects through to completion, as well as the ability to effectively delegate to and set priorities for others, required.
• Ability to solve problems and ability to implement practical solutions required.
• Ability to meet strict deadlines, flex with changing priorities, and work both independently and as part of a team, required.

What you'll get in return

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.