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SR Director, Quality Assurance (GCP/GLP)

SR Director, Quality Assurance (GCP/GLP)

Skills Alliance Enterprise provided pay range

This range is provided by Skills Alliance Enterprise. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$300,000.00/yr - $330,000.00/yr

Sr. Director Quality Assurance (GLP/GCP)

6-month contract-to-hire

Hybrid: Working from South San Francisco, CA and remote. Some travel may be required.

We are partnered with a biotechnology organization that believes in the potential of engineered cells as medicine, and is composed of a team that wants to lead with the desire to work on novel ideas. Our client is in the clinic with their lead CAR T programs in autoimmune disease and oncology and developing cell and gene therapies in autoimmune disease, oncology, and type 1 diabetes.

As a Senior Director of QA, you'll report to the Chief Medical Officer. You will lead Quality projects and set Quality expectations for GCP- and GLP-regulated work to ensure compliance with applicable regulations and standards.

As a Global Quality Assurance Leader, you will develop, implement, and communicate our quality strategy and programs.

The Senior Director of Quality (GLP/GCP) will be responsible for the strategic approach to Quality as well as leading and managing Quality systems and activities. You will design, prioritize, implement, monitor, and communicate GLP/GCP quality strategy and quality programs. Further, you will establish and translate the organization's quality strategy into operational policies and procedures and training to meet global regulatory, medical/health, and legislative standards.

We are looking for the experience, knowledge, and leadership credibility to be effective in multiple capacities, thereby ensuring compliance with Quality standards and corporate-wide commitment to Quality principles. As the organization grows, you will help build a team to ensure compliance and operational efficiency.

What you'll do:

• In this highly visible role, you will oversee Quality- related activities that support non clinical and clinical work.
• Manage and sustain a Quality Management System (QMS) that conforms to corporate standards and regulatory requirements and effectively implements this system across the organization.
• Serve as a subject matter expert on GCP/GLP audits/vendor qualifications, quality investigations (QE, Deviation, CAPA), SOPs and policies, and training programs.
• Identify training needs related to GCP/GLP training for SOPs, policies, and clinical study specific training for GCP/GLP employees and ensure comprehensive training is provided to maintain compliance.
• Design and maintain Quality systems that improve GCP/GLP compliance,
• Provide senior-level leadership regarding GCP/GLP quality strategy and operations for leadership and cross-functional project teams
• Generate and analyze key performance metrics on a quarterly basis to track performance and report during quality management review meetings with leadership.
• Support program teams; provide direction on interpretation of global quality regulations and guidance documents
• Oversee GLP quality and compliance including vendor qualification and GLP bioanalysis.
• Review of clinical study protocols and reports, and regulatory submissions, as needed
• Ensure practices are compliant with FDA, ICH (R3), EMA, and industry standards
• Collaborate and establish/maintain procedures in collaboration with Development, Clinical Operations, Regulatory Affairs, and Technical Operations to ensure the nonclinical/clinical study activities are conducted according to GxP compliance regulations, guidelines, and practices.
• Develop and maintain an audit program for clinical sites, CROs, and contract laboratories
• Collaborate and resolve complex issues regarding supplier, partner, vendor performance
• Provide GCP/GLP quality guidance and partner with key stakeholders to resolve quality compliance issues and support with quality event management, protocol deviations, risk management, issue escalation and CAPA development. Ensure suitability of corrective and preventive actions, verifying CAPAs to completion and keeping management informed of CAPA metrics

What we're looking for:

• Bachelor's degree required, advanced degree in relevant scientific field is a plus
• 7+ years of relevant experience within biotechnology or pharmaceutical industry; including in development of complex biologics (such as gene therapy, vaccines, monoclonal/conjugated antibodies, enzyme replacement therapies), and small molecules
• Thorough understanding of industry regulatory environment related to Quality Systems; ability to evaluate complex situations and to provide practical perspectives for evaluating regulatory, financial, or legal risks and mitigations especially where compliance guidelines are inadequate
• Be highly effective having difficult conversations on a routine basis internally or externally with partners; must be able to preserve the relationship while confronting quality issues that create unacceptable risks for the organization
• Is intellectually curious, innovative, and practical/flexible

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

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