Quality Assurance Manager

Job not on LinkedIn

September 10

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $135k - $145k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Akero Therapeutics

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

11 - 50 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Provide QA oversight 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 substance and/or drug product. • Monitor compliance with quality agreements, ensuring third parties adhere to contractual and regulatory obligations. • Review and approve deviations, CAPAs, change controls, and investigations originating at CDMOs/CTLs. • Ensure robust root cause analysis and effective CAPA implementation to prevent recurrence. • Oversee data integrity compliance and enforce adherence to ALCOA+ principles. • Maintain and apply up-to-date knowledge of global regulatory requirements and provide quality input to regulatory submissions (IND, BLA/MAA, variations). • Participate in audits of CDMOs and CTLs; support and lead regulatory inspections as the quality representative for outsourced operations. • Serve as the primary QA point of contact for outsourced operations and collaborate with internal Manufacturing, QC, Regulatory, and Supply Chain functions. • Provide guidance and training to internal stakeholders on quality and compliance in a virtual company model. • Identify and drive continuous improvement initiatives across the QA function and within partner relationships.

🎯 Requirements

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, or related 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 success 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 quality systems (e.g., Veeva) and strong proficiency in data integrity standards.

🏖️ Benefits

• Pay range: $135,000 - $145,000 per annum