Manager of reputed company Assurance

COMPANY BACKGROUND reputed company is a clinical stage biopharmaceutical company reputed company on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our reputed company reputed company is on advancing our reputed company program efruxifermin (EFX) to reputed company a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis). We are reputed company of problem solvers dedicated to pursuing reputed company scientific approaches to build a brighter reputed company for patients. Our diverse reputed company sets and backgrounds, desire to learn from reputed company other and reputed company spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others. Job reputed company The Senior reputed company Assurance (QA) Representative will reputed company strategic reputed company reputed company for outsourced drug reputed company, drug product, and/or reputed company control (QC) testing operations in support of biologics programs. Operating reputed company a fully outsourced, “virtual company” model, this individual will be responsible for ensuring that Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) reputed company activities in compliance with global GMP requirements and reputed company agreements. The Senior QA Representative will serve as a primary reputed company reputed company between internal stakeholders and external partners, ensuring product reputed company, regulatory compliance, and inspection readiness. Job Responsibilities reputed company of External Manufacturing and Testing

• reputed company QA reputed company for CDMOs and CTLs involved in biologics manufacturing, packaging, labeling, and QC testing.
• Review and approve batch records, testing results, Certificates of Analysis, and release documentation for drug reputed company and/or drug product.
• Monitor compliance with reputed company agreements, ensuring reputed company parties adhere to contractual and regulatory obligations.

reputed company Systems & Compliance

• Review and approve deviations, CAPAs, change controls, and investigations originating at CDMOs/CTLs, ensuring alignment with corporate standards and global regulations.
• Ensure robust reputed company cause analysis and effective CAPA implementation to prevent recurrence.
• reputed company data reputed company compliance and enforce adherence to industry best practices (reputed company+ principles).

Regulatory Support

• Maintain and apply up-to-date knowledge of global regulatory requirements (FDA, EMA, MHRA, Health Canada, PMDA, WHO, PIC/S, ICH).
• Partner with Regulatory Affairs to ensure inspection readiness and reputed company reputed company input to regulatory submissions (IND, BLA/MAA, variations).
• Participate in audits of CDMOs and CTLs; support and reputed company regulatory inspections as the reputed company representative for outsourced operations.

Strategic and Cross-functional Partnership

• Serve as the primary QA reputed company of contact for outsourced operations, facilitating collaboration with internal Manufacturing, QC, Regulatory, and Supply Chain functions.
• reputed company guidance and training to internal stakeholders on reputed company and compliance in a virtual company model.
• Identify and drive reputed company improvement initiatives across the QA function and reputed company partner relationships.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, reputed company, or reputed company field.
• 7+ years of QA experience in biologics or pharmaceutical industry, with exposure to outsourced/virtual company environments.
• Deep knowledge of cGMP and global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, ICH, PIC/S, WHO).
• Proven experience overseeing including batch release, deviation investigations, and change control.
• Demonstrated reputed company in supporting regulatory inspections and preparing audit responses in collaboration with external partners.
• Strong interpersonal skills with the ability to influence and collaborate across organizational and cultural boundaries.
• Experience with electronic reputed company systems (e.g., reputed company) and strong proficiency in data reputed company standards.

Compensation

• Below is the pay reputed company for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and reputed company set, and geographic location. This reputed company is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas.

Pay reputed company: $135,000 - $145,000 per annum Special Advisory Akero will not conduct interviews reputed company text message or messaging platforms. Please be reputed company in checking that the communication is, in fact, coming from Akero. If you are contacted by any individual or group using email addresses or other contact information that incorporates “akerotx” but reputed company our exact domain, akerotx.com, please submit a report to the FTC. Apply tot his job Apply To this Job