Associate Director QA and Validation Biologics

Job Description

#1938: Associate Director Quality Assurance and Validation, Biologics

Our client is seeking a highly motivated and experienced individual for the position of Associate Director Quality Assurance and Validation Biologics, with QA and Validation responsibilities. Reporting to the Director, of Quality Assurance Development and External, and for validation responsibilities the individual will report to the Director of Validation of Quality Assurance Development and External.

Responsibilities:

• Champions GMP requirements in both routine and non-routine Biologic Drug Substance (DS) and Drug Product (DP) clinical and commercial operations.
• Manage and direct QA team members in all areas of QA Operations. Complete performance reviews and development planning, to ensure continued growth of technical depth and capability with the team.
• In conjunction with the SME, the QA team will write deviations and change control, CAPA’s and associated quality record.
• Actively manage the processes for quality events involving CDMOs such as major investigations, change management product complaints and ensure risks and trends are evaluated and managed.
• Ensure IMP/IND batch GMP manufacturing / clinical/commercial supply program continuity through batch documentation review, product lifecycle disposition, and clinical supply maintenance.
• Responsible for the escalation of critical quality issues as appropriate to Quality Management consistent with site procedure on Notification to Management.
• Deviation review and approval, issue resolution and CAPA monitoring.
• Perform batch review and approval according to company procedures and ensuring compliance to GMP standards.
• Provide the requisite quality support to functional groups such as Regulatory/CMC and in support of regulatory filings, regulatory agency questions.
• Support the external auditing program by participation in audits of Third Parties as requested.
• Champions GMP requirements in both routine and non-routine operations.
• Build strong effective working relations with CMO’s from a quality and compliance prospective.
• Proactively support regulatory inspections at the CMO sites that may impact compliance status or require regulatory notifications.
• QA lead for risk assessment and root cause analysis as required.
• Monitor and evaluation of on time closure of records. KPI data - monitor and evaluate trends, propose CAPAs to eliminate adverse trends
• Provide quality oversight at CMO to ensure compliance with the requirements of the quality agreement.
• Perform quality record /document review and approval according to company procedures and ensuring compliance to GMP standards.
• Co-ordinate PQR generation as required.
• Serve as Quality Assurance support and SME for Drug Substance/Drug product manufacture maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant.
• Expectation to be person in plant (PIP) during validation activities and for routine quality visits as required.
• Accountable for the on-time disposition of clinical/commercial products in line with the agreed schedule
• Support all PPQ process and product related activities for drug substance e.g. process characterization, cleaning validation, process validation (including e.g. stability studies, hold time studies, review and approval of protocols). Review and approval of associated documents.
• Ensure compliance of quality systems other applicable regulations/standards and internal procedures. Support implementing improvements at the CMO in deviation and change control systems.
• Provide the requisite quality support to the regulatory/CMC group in support of license applications
• Keep up to date with FDA/EU regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance for product commercialization.
• Build strong effective working relations with CMO’s from a quality and compliance prospective.
• Proactively support regulatory inspections at the CMO sites that may impact compliance status or require regulatory notifications.
• Participate in internal and external audits as required.

Validation specific responsibilities:

• Ensures that the validation approach employed at the DS and DP CMO meets commercial and clinical phase appropriate requirements for US/EU and OUS regulatory territories.
• Collaborate with cross functional teams to provide validation leadership for DS/DP, Shipping and Packaging programs as required.
• Represent validation on Technology Transfer Teams to ensure validation requirements are met.
• Provide validation and technical input into CMC project teams.
• Provide validation representation, guidance and direction to CMOs, Process Development, and External operations team for Biologics Clinical and Commercial.
• Provide support to the Director of Validation and act as a designee as required, including CMC support/representation.
• Provide on-going validation support to CMOs to resolve validation related issues and evaluate and advise on any product quality related issues.
• Evaluate proposed process changes and improvements in terms of validation impact and provide a ‘calibrated’ technical review of change control requests, deviations and Master Batch Record changes.
• Support CMO Audits as QA validation Subject Matter Expert (SME) as required.
• Author/review and approve validation and validation supporting documents as appropriate (SOPs, policies, lifecycle documents, Process Control Strategies, Process Development reports, deviations, CAPAs, change controls etc.)
• Review and approve CMO validation documentation (VMP, PPQ protocols (Process & Cleaning), sampling plans, and Validation Summary Report (VSR ) etc.)
• Provide QA validation oversight for regulatory submissions for Biologics.

Skill / Abilities:

• Thorough understanding and working knowledge of current quality and validation related regulatory requirements and expectations for (US, OUS, International Conference of Harmonization (ICH) and European) with the ability to determine phase appropriate quality and validation requirements.
• Demonstrate strength in people management, written and oral communication, leadership, and project management skills.
• Have strong negotiation skills
• Demonstrated ability to prioritize work to act and work independently
• Has a strong broad GMP and technical ‘know how’ to handle emerging issues.
• Competent in the use of electronic systems to support own role and departmental requirements.
• Competent in application of data integrity requirements.

Qualifications:

• Masters/BS in scientific discipline or equivalent.
• 10 years’ experience in quality/validation in the pharmaceutical industry; preferably in biologics/ sterile manufacturing, with 2 years + leadership/management experience.
• Prefer specific education or certification in adult learning and/or quality management.
• Experience in oversight of CMO quality and validation operations preferred
• Ability and experience with supporting regulatory audits (FDA, EMEA, PMDA etc.) in support of pre-approval and general inspections.