Associate Director, Quality Assurance

South San Francisco, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

The Associate Director of Quality Assurance must have experience in pharmaceutical manufacturing, with a primary focus on overseeing Quality Control (QC) data for stability studies and lot release. This role requires a strong understanding of cGMP, FDA, EMA, and other relevant regulations, as well as experience with data review and approval processes for various product stages. Experience with CMO oversight and knowledge of CMC regulatory submissions are also important qualifications.

Responsibilities

The Associate Director of Quality Assurance will provide QA oversight for QC-generated data, ensuring compliance with regulatory standards for product stability and lot release. Responsibilities include reviewing and approving stability protocols, OOS/OOT investigations, trend reports, and Certificates of Analysis (CoAs). The role involves collaborating with Technical Operations, Global Supply Chain, and Regulatory Affairs, as well as overseeing QC activities at CMOs and ensuring all records adhere to cGMP/GDP expectations.

Skills

Quality Assurance

Quality Control

GMP

Data Integrity

Regulatory Compliance

Stability Studies

Lot Release

Pharmaceutical Manufacturing

cGMP

FDA

EMA

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

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