Senior Manager, Quality Assurance Operations
- Employer
- MyoKardia, Inc (acquired by BMS)
- Location
- Brisbane, California, United States
- Start date
- Sep 5, 2020
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- Discipline
- Manufacturing & Production, Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
The successful candidate should be able to perform the following QA Operations responsibilities and activities. This includes but is not limited to:
- Develop quality oversight strategy for selected contract manufacturing organizations.
- Act as Quality lead for program in GMP manufacturing.
- Perform QA GMP vendor audits and write audit reports with findings, when necessary.
- Advise, review and approve master batch records and executed batch records.
- Responsible for lot disposition for selected contract manufacturing organizations by performing review and approval of QA certificate of release of product and approval of validation master plans (VMPs), process validation protocols and reports.
- Review and approval of analytical methods, product specifications, analytical method validation protocols and reports.
- Review and approval of stability protocols, data tables and stability reports.
- Develop, advise, review and approve Quality Systems documents (procedures, specifications, protocols, deviations, CAPAs, etc.),
- Manage, review and approve change controls (CC) and CC packages for closure.
- Investigate, manage and approve product complaints reports for closure.
- Assist with product recall / stock recovery investigations and reports, as necessary,
- Assist with administration of the Quality Systems, as necessary.
- Partner with Manufacturing, Formulation Development, Technical Operations, Analytical Chemistry, and Quality Control to ensure products are delivered on time and within specification.
- Work collaboratively with cross-functional project teams.
- Serve as MyoKardia's quality liaison with contracted manufacturing organizations (GMP manufacturing, QC testing and/or other vendors), as necessary.
- Presenting as subject matter expert (SME) during regulatory inspections.
- Stay abreast of changes in applicable FDA and European regulations, directives and guidelines and determine potential impact on company GMP activities.
- Must be capable and willing to travel (up to 25%), including international travel.
- Maintain flexibility to perform other / additional tasks as assigned.
- BS/BA degree in a scientific field required; advanced degree is a plus
- ASQ certification a plus
- Typically requires a minimum of 10+ years in biotech/pharmaceutical industry, with 8+ years of Quality Assurance experience
- Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
- Excellent oral and written communications skills
- Excellent organizational skills, with ability to successfully manage multiple priorities
- Strong influencing skills: proven ability to get things done
- Ability to work effectively with cross-functional teams
- Late stage drug development, Regulatory (NDA) submission and commercial manufacturing experience.
- Experience with inspection readiness process and able to provide recommendations for its continuous improvement
Company
MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science. MyoKardia is a clinical-stage bio pharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by 1) understanding the bio mechanical underpinnings of disease; 2) targeting the proteins that modulate a given condition; 3) identifying patient populations with shared disease characteristics; and 4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia’s initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224. Founded in September 2012 MyoKardia is headquartered in Brisbane, CA.
- Website
- http://www.myokardia.com/
- Phone
- 650-741-0900
- Location
-
1000 Sierra Point Parkway
Brisbane, CA 94005
US
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