Quality Systems Manager - South San Francisco, United States - Cytokinetics
Description
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.
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, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.
Cytokinetics is seeking a highly motivated individual to join our team as Quality Systems Manager.You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch You will lead various aspects of the Quality Systems, ensure compliance with company's procedures, company policies, and regulatory guidelines.
ResponsibilitiesProcess controlled documents in the electronic document management system throughout its lifecycle (e.g. SOPs, Policies, Work Instructions, Forms)
Perform formatting and editing of controlled documents prior to routing for approval
Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle
Track and manage document control activities, including management of periodic reviews
Collaborate with functional areas to determine appropriate training assignments and assign accordingly
Support and collaborate with stakeholders for annual review of training assignments and training roles
Monitor and drive training compliance
Generate and analyze metrics for report out to management and cross-functional areas to ensure routine monitoring of quality system health
Support maintenance of the electronic document management system and learning management system
Identify and support continuous improvement opportunities within Quality Systems
Participate on cross-functional teams representing Quality as appropriate
Support and participate in audits and inspections, and act as subject matter expert for document management and training systems
Other duties, as assigned by management
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.
QualificationsBachelor's degree in a scientific field, with 8+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area, specifically with strong experience in Document Control and Training
Must be highly organized with a strong attention to detail
Must have advanced skills in MS Office Suite, particularly in Word document processing and formatting
Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems
Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple
Ability to work in a collaborative team environment is essential, with a customer-focused approach
Strong decision maker with the ability to utilize critical thinking to problem-solve
Must have strong interpersonal and communication skills
Experience writing, reviewing and editing SOPs, as well as other document types
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$135,000
—
$165,000 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.
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.Please visit our website at:
Cytokinetics is an Equal Opportunity Employer
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For government reporting purposes, we ask candidates to respond to the below self-identification survey.
Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Cytokinetics's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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A "disabled veteran" is one of the following: a veteran of the U.S.
military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S.
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military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
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