Senior Director, Quality Assurance
Alkahest, Inc., a clinical-stage biotechnology company focused on developing innovative therapies to treat age-related diseases, is seeking a Senior Director of Quality Assurance (QA) to lead the QA support for drug development across an exciting array of new products. This hands-on leadership 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 Alkahest management to provide proactive strategic guidance, set policy, and address compliance issues.
Starting from the day you join, you will jump into 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.
- Establish and maintain quality systems and implement process improvements as needed to ensure GCP, GMP, and GLP 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 and availability of both internal and external GxP and program-level training, including providing training as needed, e.g., new regulations, audit findings, etc.
- Establish and manage quality assurance programs, as appropriate
- 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
- Identify and address GCP risk signals and implement 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 QA-Controlled procedures
- Participate in outsourcing vendor evaluation and selection, conduct vendor audits, as appropriate; ensure robust vendor oversight, and establish Quality Agreements
- 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
- Lead cross-functional efforts to identify and address potential instances of fraud / scientific misconduct, as appropriate
- 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 upper management of potential issues impacting Alkahest’s business processes
The Ideal candidate is/has:
- 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; and 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 understanding and interpretation of GCPs, GLPs, GMPs and best quality practices in regards to 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
Please send Cover Letter with CV.