Manager, Clinical Quality Compliance

The Manager, R&D Quality Assurance (QA) will support the organization by providing GCP/GVP/GCLP/GLP (GxP) QA oversight for research & development (R&D) activities required at all stages of the organization's products' life cycle. Reporting to the Director, Clinical Quality Assurance, this individual will have responsibility for QA oversight of GxP activities, its contract research organizations (CROs) and Investigator Sites to ensure that outsourced third parties (CROs and other GxP service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections and to ensure that the appropriate processes, systems and activities are in place and performed to protect the rights, safety and welfare of our clinical patients. This individual will also oversee, assess and directly work to continuously improve GxP quality processes and to support the state of GxP compliance at the organization. This is an opportunity to help develop the GxP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization. This person will manage cross functional relationships with internal and external stakeholders and be the Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners. Effective communication, priority management, and compliance management tracking, reporting, and problem solving will be core skill sets for this role.

About the Role:

• Support the R&D QA Strategy
• Represent R&D QA at program team
• Perform R&D QA risk
• Represent R&D QA on process improvement
• Lead and support R&D QA GxP Inspection readiness efforts and activities during preparation, conduct, and follow-up for Regulatory Agency
• Build and foster cross-functional partnerships throughout the organization, supporting and leading Quality initiatives, as appropriate.
• Facilitate and oversee audits, deviations and
• Serve as a R&D QA subject matter expert for controlled documents (i.e. SOPs, WIs,) and R&D QA training and for these topics during audits and inspections.
• Monitor GxP non-conformance trends and communicate this information to management with proposed remediation actions.
• Track GxP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory
• Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance
• Support GxP compliance and alliance activities with vendors and business partners and lead Quality Agreement creation, management and revision.
• Perform other duties as requested by the leadership team.

About You:

• Bachelor's Degree or equivalent work experience in a scientific or technical discipline.
• Five (5) or more years of Quality Assurance experience in a GCP-focused role, or equivalent work experience.
• Quality and compliance background, preferably related to GCP/GVP/GCLP/GLP.
• Demonstrated analytical and process skills and the ability to apply these skills to the organization.
• Effective communication, consulting, customer service and problem-solving skills.
• Must be detail oriented, capability to meet deadlines.
• PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required).
• Excellent time and project management skills.
• Strong interpersonal skills and ability to interact with all levels of the organization and cross- culturally.
• Build positive relationships with regulators, inter and intra-departmental customers, internal and external stakeholders.
• Global mindset required.
• Demonstrated ability to influence others.