Senior Specialist or Manager, Quality Assurance

Alkahest, Inc., a clinical-stage biotechnology company focused on developing innovative therapies to treat age-related diseases, is seeking a Senior Specialist Quality Assurance (QA) or Manager QA to aid the Sr. Director, QA in supporting drug development across an exciting array of new products. This hands-on position will be responsible for executing quality activities focused on continuous improvement of quality and compliance across programs, Project Teams, and Functional Areas and will work with Sr. Director, QA along with Alkahest management to implement proactive policies and procedures.

Starting from the day you join, you will jump into assisting Sr. Director, QA with setting up quality systems and supporting development teams, creating, and implementing quality assurance programs, as appropriate, for all Alkahest programs. You will need to rapidly absorb relevant information on Alkahest products and their place within the development process, collaborating and communicating with stakeholders at all levels, both within and external to the Company.

If you have the work ethic and mental agility to embrace a very fast paced and rapidly evolving environment, you will be rewarded through diverse and exciting experiences. This is your chance to add value to an entrepreneurial organization that supports innovation and welcomes passionate, team-oriented colleagues looking for a deeper understanding of human aging in order to improve the health span of patients worldwide.

Responsibilities include:

• Assist with establishing and maintaining quality systems and implementing process improvements as needed to ensure GMP, GCP, and GLP compliance in an early clinical development environment as the products advance to late-stage development and potential commercialization.
• Manage both internal and external GxP and program-level training, including providing training as needed, e.g., new regulations, audit findings, etc.
• Represent Sr. Director, QA 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.
• Identify and address GXP risk signals and recommend preventative measures; assist internal and external personnel (e.g., investigator sites and vendors) in the development of corrective and preventative action plans following identification of compliance issues/concerns; monitor progress on successful completion; review / approve deviations and procedures
• Participate in outsourcing vendor evaluation and selection, conduct vendor audits, as appropriate; ensure robust vendor oversight, and review Quality Agreements.
• Assist with 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.
• Participate in due diligence audits of potential business partners.
• Manage audit program for investigational sites, utilizing findings to improve procedures and/or coach clinical teams.
• Maintain awareness and inform Sr. Director,  QA of potential issues impacting Alkahest’s business processes.

 The Ideal candidate is/has:

• A BA/BS, in a scientific discipline or related field
• Certified Quality Auditor or equivalent certification preferred.
• Greater than 5 years’ experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industry
• Ability to work independently with minimal supervision; and the ability to impact and influence with appropriate negotiation and presentation skills
• Knowledge and experience with phase-appropriate quality assurance systems to achieve and maintain GxP compliance
• Strong understanding and interpretation of GMPs, GCPs, and/or GLPs and best quality practices in regards to biotech and pharmaceutical products
• 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