Head of Quality Assurance

Alkahest is seeking a Head of Quality Assurance (QA) to join our team, leading a Quality Assurance department that combines external QA consultants with an in-house model, supporting Alkahest’s development pipeline.  This hands-on leadership position will be responsible for GxP Quality activities across the Alkahest portfolio of early development programs.  You will work with Alkahest senior management to provide proactive strategic guidance, set policy, and address compliance issues.

Responsibilities

• Implement process improvements as needed to ensure GxP compliance in an early clinical development environment, with a strategic view to grow the Quality function as the products advance to late-stage development and potential commercialization
• Ensure the adequacy of the Alkahest Quality Management System (QMS) components, including creation and revision of SOPs and training programs for GxP compliance, and documentation of QMS-required training
• Ensure GxP technologies are validated and validation is maintained according to industry standards
• Represent Quality Assurance on cross-functional teams, as appropriate, and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices
• Work with internal R&D functions and external parties including development partners, consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs.
• Oversee or lead inspection activities (preparation, conduct, and response) for regulatory inspections internally, and at investigator sites, when appropriate; facilitate internal reviews of processes; assist in preparation of responses to findings; ensure completion of commitments
• Identify and address risk and implement preventative measures; assist in the development of corrective and preventative action plans following identification of compliance issues/concerns with both internal and external personnel (e.g., investigator sites and vendors); monitor progress on successful completion; review / approve deviations and QA-Controlled procedures
• Participate in outsourcing vendor evaluation and selection, conducting vendor audits as appropriate; ensure robust vendor oversight, and establish Quality Agreements
• Provide expertise and guidance on GxP activities and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation
• Lead investigations into significant quality issues, suspected scientific misconduct and suspected serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate
• Manage audit program for investigational sites, utilizing findings to improve procedures and/or coach clinical teams
• In collaboration with subject matter expert, provide quality oversight related to GMP activities including oversight and approval of Method Validation, Release testing, and Stability for Drug Substance and Drug Product
• Work cross-functionally with CMC and CMOs to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
• Review and approve CMO master documentation (e.g., specification documents, master batch records, label proofs, etc.), as well as perform review of executed batch records, applicable test data (in-process and release) and performing product dispositions
• Work with Qualified Persons (QP) to support QP certification for distribution in EU/UK
• Maintain awareness and inform upper management of potential issues impacting Alkahest’s business processes

Qualifications

• A BA/BS, MA/MS or PhD in a scientific discipline or related field
• Greater than 8 years’ experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industry
• Ability to translate strategy into action with minimal supervision; the ability to impact and influence with strong negotiation and presentation skills
• In-depth knowledge and experience implementing phase-appropriate quality assurance systems to achieve and maintain GxP compliance
• Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products.
• Strong understanding and interpretation of GCP, GLP, GMP and best quality practices for biotech and pharmaceutical products
• Experience with, and responding to, regulatory agencies (e.g., FDA, EMAMHRA, and BfArM) preferred
• Excellent interpersonal and written and oral communication skills, ability to develop important relationships with customers and key stakeholders, good conflict resolution skills
• Demonstrated ability to be results and detail-oriented; self-motivated