Associate Director, Quality
Location: Remote, Experience: 10 plus years, Type: Full-time Exempt
Vaxxinity is a clinical-stage immunotherapeutic company formed through the combination of COVAXX and United Neuroscience, two independent subsidiaries of United Biomedical (one of the leading vaccine companies in the world consisting of seven operating entities). Led by a female CEO, in an informal values-driven start-up culture, Vaxxinity will control half a dozen development candidates targeting neurologic disorders, hypercholesterolemia and COVID-19. Vaxxinity is currently pre-selling and ramping up production and distribution for hundreds of millions of COVID-19 vaccines.
You will collaborate with a group of inspiring colleagues all over the globe who are working on disruptive projects, solving big problems, and having a huge impact on the world. Vaxxinity is an international company, operating remotely from day one across several countries and team members worldwide. Expect to grow, expect to be challenged, and expect the unexpected as we embark on this journey of democratizing health for all the world’s citizens.
We are searching for a polished, smart, passionate, caring, self-motivated Associate Director Quality. The ideal candidates will bring wisdom, enthusiasm, integrity, focus and perspective for the execution of Vaxxinity’s Quality System and associated support processes and will interface directly with third-part vendors, Research, Development, CMC, Clinical Development and Operations leadership teams to support and achieve compliance goals. Some interface and influence of leadership is required with input on key global QA / Compliance and business initiatives. Responsible for the monitoring of external regulatory compliance environment and making recommendations to Management on tactical issues impacting business.
Responsibilities (duties are not limited to the below and may evolve over time depending on business needs and individual expertise)
- Manage and implement GxP Quality systems including oversight and management of trial master file, archive SOPs, training, and internal audit program.
- Provide strategic direction for electronic quality system setup and configuration.
- Collaborate and establish, maintain procedures with technical teams to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GxP requirements.
- Host and manages Board of Health and third-party Audits.
- Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of, bulk substance, drug product, packaged and labeled drug products.
- Lead investigations for any non-conformances during GxP activities.
- Lead and conduct GxP audits on suppliers, issue audit agendas, reports, findings, perform follow-up actions and escalate findings to management as necessary.
- Oversee GCP compliance with respect to clinical site and CRO audits.
- Oversight, management, and qualification of all GxP vendors.
- In conjunction with Clinical Operations management, assures appropriate oversight of clinical trial execution.
- Conduct pre-audit and pre-inspection quality reviews to ensure better audit/inspection outcomes; Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings.
- Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GMP, GLP, and GCP.
- Maintain compliant quality system that adheres to FDA regulatory expectations both internally and with respect to oversight of the company’s suppliers.
- Work with CMC, non-clinical, clinical, regulatory, etc. as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and regulatory inspections to ensure that the organization is inspection ready.
- Interfaces directly with Research, Development and Clinical; actively influence and participate on quality compliance initiatives from a tactical GxP compliance perspective.
Education / Experience
- 10 plus years of experience with increasing levels of responsibility within the Quality and/or Compliance area. This includes hands on experience with managing inspections within the Clinical and R&D areas.
- S. in Biology, Chemistry, Engineering or related fields preferred.
- Knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections.
- Compliance / QA experience at a pharmaceutical / biopharmaceutical with specific antibody and vaccine experience.
- Extensive experience with GxP systems approaches and implementation of such systems.
- Proven ability to work in a collaborative team environment across multiple technical functions.
- Ability to effectively interact with both global functional areas (GxP) and manufacturing sites (GMP) and third-party vendors.
- Strong project management and organizational skills.
- Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills).
Knowledge / Skills / Abilities
- MS Office Suite, Google Suite, technology savvy
- Clever, flexible and resourceful -- must be able to work independently and know when/how to ask for help
- Ability to stay calm, cool, and focused in stressful times and maintain a professional demeanor
- Highly motivated, a “roll-up-your sleeves” attitude to work requirements, able to multi-task and meet rigorous timelines
- Excellent project management and prioritization skills including ability to handle multiple tasks and work in a fast-paced, time-sensitive environment
- Excellent communication skills in a wide array of situational settings from c-level interaction to core team members, imparting both vision and execution focus; deep analytical skill sets with a synthetic mindset
- Proven high level capability to concisely communicate complex and controversial issues and drive to resolution
- Demonstrated capability and passion for developing talent and a culture of innovation, collaboration and engagement
- A strong team player who supports their team and embraces ownership, accountability, and responsibility for the team’s work
- Ability to influence decision making with or without authority, facilitate groups with diverse perspectives, across geographies, and bring teams to agreement
- Strong interpersonal skills that build productive relationships and influence others across the company
- Humility and the belief you can make the world a better place is highly desired
- Be science-driven
- Communicate clearly, openly and respectfully
- Unite in teams and collaborations
- Learn and help others learn
- Act with integrity
- Get sh*t done