INACTIVE
Full-Time
Associate Director
Quality Compliance
Posted on 3/14/2024
Develops drugs for muscle function diseases
Biotechnology
Compensation Overview
$180,000 - $220,000Annually
Senior, Expert
San Bruno, CA, USA
Requirements
- Bachelor's degree in a scientific field or equivalent
- 10+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area with experience in Quality Compliance
- Experience in auditing techniques (ASQ certification is a plus)
- Strong working knowledge and interpretation/implementation of GMP regulations, familiarity with worldwide regulatory guidelines
- Experience dealing with regulatory authority inspections
- Proven management skills with the ability to lead and mentor others effectively and experience with advocating for a compliant environment
- Ability to work effectively with various technical groups and a strong working knowledge in the following disciplines: API or drug product manufacturing, analytical development/QC, product launch activities, clinical and commercial distribution channels
- Ability to work in a collaborative team environment is essential, with a customer focused approach
- Strong interpersonal and communication skills
- Strong decision maker with the ability to utilize critical thinking to problem-solve
- Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple
- Experience writing, reviewing and editing SOPs, specifications, and validation documentation as well as other document types
Responsibilities
- Establish and improve policies, procedures and systems that enable clear oversight of internal and external GMP activities
- Provide technical support with ad hoc investigations and/or targeted training as needed
- Develop meaningful metrics and interpret results to understand the health programs/systems in relation to other quality programs/system
- Participate in cross-functional teams representing Quality as appropriate
- Stay current with GxP regulations, guidelines and industry practices and provide timely updates to management and internal departments
- Develop/maintain supplier management program, ensuring requirements, plans, processes, templates, metrics and tracking system for GMP suppliers are established and maintained
- Ensure audits are performed using internal and external resources
- Establish and maintain GMP supplier compliance status across Cytokinetics audits
- Lead preparation of anticipated regulatory inspections (PAI, routine inspections, including those at contracted organizations), and partner audits using cross-functional teams
- Ensure the product complaint program is performing as intended, in compliance with regulations and business needs
- Ensure product recall or withdrawal activities, including mock recall, are performed according to protocol
- Maintain compliance to FAR/DSCSA and PDMA reporting requirements
Cytokinetics is a late-stage biopharmaceutical company focused on developing small molecule muscle activators and inhibitors to address impaired muscle function in conditions such as heart failure, hypertrophic cardiomyopathy, and neuromuscular diseases. The company's main technologies involve engineering drug candidates to impact muscle function and contractility, with the goal of discovering, developing, and commercializing potential treatments for debilitating diseases.
Company Stage
IPO
Total Funding
$1.2B
Headquarters
South San Francisco, California
Founded
1998
Growth & Insights
Headcount
6 month growth
↑ 0%1 year growth
↑ 4%2 year growth
↑ 41%INACTIVE