Senior Manager, Clinical Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Regulatory Affairs, Quality Assurance, Research & Development, and other cross-functional teams to provide guidance on GCP/GLP/GPV and compliance matters to internal clinical study teams.

• Offer tactical support for assignments and take the lead when necessary to ensure that project-related procedural documents adhere to relevant GxPs and regulatory guidelines.

• Work closely with R&D stakeholders to deliver Quality support for clinical and pre-clinical programs.

• Oversee clinical site audits and vendor qualification audits.

• Ensure comprehensive quality management by proactively maintaining compliance according to the Clinical Development Plan (CDP).

• Coordinate with Global Audits and Compliance to disseminate lessons learned from audits and inspections while aiding in the implementation of corrective actions.

• Assist in CRO-related meetings by providing quality overviews or training as needed.

• Facilitate the development and execution of Corrective and Preventive Actions (CAPAs); manage and review CAPAs throughout their definition, implementation, and closure stages.

• Aid formal investigations and escalate critical unresolved issues to management.

• Identify opportunities for continuous process improvement and engage with QA and stakeholders.

• Support interactions with internal and external contacts as well as Health Authorities.

• Assist program teams in preparing for FDA, EU, and key Health Authority inspections; provide support for inspection management and follow-up activities post-inspection.

• Interpret regulations, company process standards, guidelines, policies, and procedures for assigned programs and continuous improvement initiatives.

• Support or lead the creation and implementation of study/program-specific quality plans.

• Resolve vendor-related issues for assigned programs.

• Ensure that assigned program protocols are operationally feasible and address potential risks with stakeholders.

• Conduct internal audits that support the Quality Systems internal audit program.

⛳️ Requirements

• Bachelor's Degree in Life Sciences, Pharmacy, or Nursing is required.

• A Master's Degree or another advanced degree is preferred.

• A minimum of 5 years of experience in Quality Assurance and/or Clinical Operations in regulated activities or equivalent experience is required.

• A minimum of 5 years of broad understanding of global expectations from Health Authorities regarding the management of clinical trials is preferred.

• A minimum of 5 years of extensive knowledge of international GCP/GLP regulations, including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance, and current industry practices is preferred.

• Proficiency in spoken and written Mandarin Chinese is highly desirable.

• Willingness to travel up to 20% is required.

• Proficient in using the standard MS Office suite (e.g., Word, Excel), with experience using electronic document management systems and document review tools being desirable.

• Strong computer and database skills are essential.

• A keen attention to detail, accuracy, and confidentiality is required.

• Excellent oral and written communication skills are necessary.

• Outstanding organizational abilities are crucial.

• Critical thinking, problem-solving skills, and the ability to work independently are required.

• Must effectively manage multiple tasks and handle time-sensitive and highly confidential documents.

• Ability to communicate effectively and present complex ideas in a clear and understandable manner is essential.

• Skills in prioritizing conflicting demands are necessary.

• Ability to work in a fast-paced, demanding, and collaborative environment is a must.

• Fluency in Mandarin is highly preferred but not mandatory.

🏝️ Benefits

• Potential bonus opportunities.

• Stock options.

• Benefits and/or other applicable variable compensation.

• An equal opportunity employer committed to fostering a diverse environment.