Clinical Quality Assurance Manager

Direct Biologics is a market leading innovator and science-based cGMP manufacturer of regenerative biologic products. We are currently looking for a Clinical Quality Assurance Manager.

General CQA Responsibilities:

• Create risk-based Quality Audit Plans for each clinical trial study / program and ensure they are implemented and executed.
• Perform Vendor, Investigator Site, PV, and document audits. Manage the risk management for planning GCP audits.

• Perform final site regulatory approval and release of IMP.
• Occasional quality control review of packaging and shipping activities which includes approving records.
• Supports VP of Quality with tasks related to product quality including but not limited to IMP temperature excursions, document reviews/approvals, and risk assessments.

• Assist Regulatory Affairs by providing content for Safety reports, Annual Reports, INDs, BLA’s, and amendments.

• Provide CQA oversight and auditing of eTMFs.

CQA QMS Responsibilities:

• Coordinates and authors the development, review, comment management and approval of GCP related policies and procedures.

• Assures that procedural documents have the appropriate SME review and do not conflict with other procedures or overall GCP requirements.

• Maintain Clinical Development Glossary as it relates to Policies and SOPs.

• Coordinate Training on SOPs/Policies/Work Instructions (WIs) as related to Clinical Development.

• Assist the VP of Quality with establishing annual training for Clinical Development.

• Facilitates and assists in the development of Clinical Corrective and Preventative Plans.

• Assist the VP of Quality with the management and coordination of sponsor inspections, and other regulatory agency sponsor inspections of offices in relation to GCP activities.

• Perform Internal Audits for other departments.

Requirements

• Strong understanding of clinical development and study processes as they relate cross-functionally.
• Experience writing SOPs (ideal if you have written Work Instructions, Forms/Templates).
• Experience in metrics design, risk assessments and evaluations to provide program/study level quality oversight.
• Excellent communication skills and ability to work with people in all levels of the organization and externally.
• Excellent project management and organizational skills.
• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
• Ability to deal with cross-functional teams from Clinical Development.
• Understanding of quality risk management and quality by design principles.
• Demonstrates skills in problem solving, works independently and in a team environment.
• Ability to multi-task and manage conflicting/changing priorities
• 3–6 years pharma experience (minimum of 4 years in a GCP environment working in a Clinical Compliance group)
• 3+ years’ experience conducting GCP audits (including internal PV audits, Site QA audits and vendor audits)
• Bachelor’s Degree in a life-science
• Must be willing to travel up to 25% for onsite audits and company meetings
• Demonstrates competency in the design/development of SOPs, supporting documents and performance support tools
• Experience using Electronic Document Management Systems is preferred

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option