Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Overview
Reporting to the Vice President of Quality (GXP), the Senior Director, Quality Systems and Compliance will lead the strategy for GMP quality systems and compliance programs in accordance with regulations, guidelines, and industry standards. This leadership role is responsible for overseeing the development, implementation, and maintenance of a comprehensive enterprise-level quality management system and oversees the QA Compliance team responsible for audit and inspection management and supplier qualification. The ideal candidate will have extensive experience leading and overseeing GMP quality systems and GMP compliance programs, with deep understanding and demonstrated working knowledge of CFRs, ICH guidance documents, and other regulations that govern GMP compliance during clinical development and commercialization of drug product.
Responsibilities
Full strategic responsibility for the GMP Quality System and Compliance teams, including but not limited to, the following:
- Provide strategic leadership in quality compliance and build and maintain best-in-class quality systems.
- Oversee change management, quality governance, document control, training, compliance, complaint management, product recall, supplier qualification program.
- Lead group responsible for GMP internal audits, external supplier audits, regulatory inspections, and quality agreements.
- Responsible for performance management, coaching, and development of a team of approximately 10 direct and indirect reports, and spearheading quality improvements.
- Strong partnership with Clinical Development teams, Global Supply Chain and Technical Operations during development phases through commercialization.
- Partner with peer QA teams, including the Head of Quality EU / Qualified Person to develop a consistent global strategy and approach to ensure processes and documents withstand regulatory scrutiny.
- Provide advice and guidance to the company's staff and external suppliers regarding GMP requirements.
- Partner with QA Operations for creation of annual product review.
- Evaluate and identify gaps in Cytokinetics programs, develop remediation plans for full compliance.
- Develop and maintain KPIs and data to measure effective operation and compliance.
- Budgetary responsibility for your span of control. Tracking and management of performance to budget
- Additional duties as assigned by management
Qualifications
- BS degree in Pharmacy, Biology, Chemistry, Life Science, or equivalent with 17+ years of experience in pharmaceutical industry in quality assurance or in combination with manufacturing, with 12+ years in leadership positions
- Proven experience leading GMP Quality Systems and Compliance organization in clinical and commercial manufacturing environment
- Direct experience managing regulatory inspections
- Experience building and leading teams, including management of direct reports
- In depth knowledge of cGMP regulations and compliance
- Robust understanding and knowledge of quality assurance concepts, investigations, and process improvements
- Ability to motivate a team, recognize and develop good talent and bring out the best of each individual
- Ability to drive functional, technical, and operational excellence. Ability to inspire and foster collaboration, transparency, and team effectiveness
- Excellent communication and coaching skills (verbal and written)
- Strong organizational skills and ability to effectively manage multiple priorities and ambiguity
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$252,000—$308,000 USD
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
- We do not conduct job interviews through non-standard text messaging applications
- We will never request personal information such as banking details until after an official offer has been accepted and verified
- We will never request that you purchase equipment or other items when interviewing or hiring
- If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
What We Do
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, we are developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
Proud to be a San Francisco Business Times Best Place to Work in 2021 and 2022, a Great Place to Work-Certified company in 2022 and a part of Fortune's Best Workplaces in the Bay Area in 2022 and Fortune's Best Workplaces in BioPharma in 2022.
