Company Overview:
Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients’ lives by advancing novel therapies to address unmet medical needs.
The Manager/Sr. Manager of Quality Assurance will play an important role in our organization, assisting in oversight of quality for multiple key pipeline assets. This individual contributor role provides oversight of GxP Quality and Quality System Operations in support of Candid’s development programs. This includes oversight of CDMOs and quality system execution. Actively participates in cross functional team collaboration in the development of quality culture and a compliant organization.
Responsibilities:
· Perform product batch review and disposition of clinical drug substance, drug product, packaging and labeling.
· Review and approve specifications, stability protocols, data, and reports for drug substance, drug product, intermediates, and reference standards.
· Provide quality support for operations at external manufacturing sites and/or contract analytical laboratories including the review of deviation, change control, CAPA, complaints, and laboratory investigations.
· Assist with the management of quality systems, including review and approval of procedures and policies in accordance with applicable regulatory requirements.
· Assist with GxP vendor management, including qualification activities and review of quality agreements.
· Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.
Qualifications:
· Bachelor’s degree (or equivalent) in life sciences, engineering, quality or professions (pharmacy, medicine, nursing, or other allied health sciences) minimally required.
· At least 5 years (Manager), 7 years (Sr. Manager) of relevant Quality Assurance experience in pharmaceutical/biotech company, actual title to be determined based on relevant experience
· Must be able to work independently and thrive in an entrepreneurial, fast-paced, and dynamic work environment.
· Must be organized and be able to communicate effectively.
· Must have demonstrated excellence in trial management skills, with track record of successfully and concurrently managing multiple projects, trials, and priorities.
· Ability to work well with global, multi-disciplinary teams.
· Excellent oral and written communication skills.
· Up to 25% travel.
