Director, Quality Assurance

Parsippany-Troy Hills, New Jersey, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalsIndustries

Requirements

Candidates must possess a minimum Bachelor's degree in Life Sciences, Engineering, or a related field, with over 10 years of experience in pharmaceutical manufacturing, including at least 5 years in senior QA leadership. A strong understanding of GxP, FDA regulations, and industry standards is essential, along with proven expertise in managing quality systems, leading audits, and ensuring regulatory compliance. Excellent leadership, communication, risk management, and CAPA process skills are required, and while not mandatory, a Certified Lead Auditor qualification and familiarity with quality systems like Veeva and LIMS are preferred.

Responsibilities

The Director, Quality Assurance will lead and mentor the QA team, develop strategic quality plans, and serve as a key member of the site leadership team. Responsibilities include ensuring adherence to GxP standards, managing regulatory inspections, overseeing batch record reviews and product release, and managing the quality system (deviations, complaints, recalls, change control, validation). The role involves driving continuous improvement, overseeing QA training, collaborating with other departments, leading internal and external audits, managing the QA department budget, and providing leadership on quality and regulatory issues.

Skills

Quality Assurance

Regulatory Compliance

GxP

Leadership

Mentoring

Strategic Planning

Risk Mitigation

Product Quality

Patient Safety

Team Management

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees