Associate Director – GMP Quality Compliance

Associate Director – GMP Quality Compliance

Requirements

• Demonstrated experience in Quality/Technical GMP manufacturing operation.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA.
• In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.).
• In depth knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Critical Thinking and problem Solving with ability to evaluate quality matters and make decisions utilizing risk based approach.
• Ability to independently influence and effectively communicate with business stakeholders.
• Strong leadership skills with the ability to thrive in a high throughput environment.
• Results driven and attention to detail to execute in a QA operational role.
• Excellent collaboration skills, and teamwork to partner within Quality and with stakeholders.
• Bachelor’s degree in a biotech/ Lifesciences field.

Responsibilities

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions.
• Participates in cross-functional teams as an experienced Quality technical resource.
• Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls.
• Be the Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations.
• Ensures appropriate CAPA actions are identified and addressed.
• Maintains Quality Metrics to support process improvement activities.
• Proactively identify, assess and mitigate risks and gaps to cross-functional quality systems and technical quality processes.
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Supports audit programs and inspection readiness including assisting in preparation of audit responses for Cell & Gene Audits.
• Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
• Execute improvements to QA operations processes.
• Participate/ lead Cell & Genetic Program and Quality projects and drive continuous improvement activities.

Preferred Qualifications

• Preferred Master’s degree or relevant comparable background
• 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
• Experience in Cell or Gene therapies is preferred