MountainViewRecruiter Since 2001
the smart solution for Mountain View jobs

Manager, Quality Assurance

Company: Minaris Regenerative Medicine
Location: Mountain View
Posted on: April 8, 2021

Job Description:

Manager, Quality Assurance

The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.

The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation.

Essential Functions And Responsibilities

Ensure the safe release of cellular products in accordance with company and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Establish and maintain policy for documentation of all products and perform internal documentation audits.
Author and review relevant SOPs, validation and other documents.
Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.
Control Master Batch Records, distribution and label verification
Perform line clearance activities as required.
Assign and maintain product lot numbers as applicable.
Ensure materials management nonconformance disposition and release activity as applicable.
Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
Provide support to manufacturing for investigations of deviations, validations, and development of specifications
Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.
Perform employee training on QSR and ISO requirements and company quality systems
Perform document control activities as assigned.
Mentor/train/develop and manage Quality Assurance team.
Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements


Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
BS Degree in biological sciences or equivalent.
Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
Sound knowledge of aseptic processing and supporting technologies.
Analytical and technical troubleshooting skills are a plus.
Proficient with Microsoft Office Suite
Excellent organizational skills and attention to detail.
Good verbal and written communication skills.

Strong Team-oriented Interpersonal Skills Are Essential.

Travel may be required

Competencies/Candidate Profile

Strong business acumen
Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem-solving skills
Strong written and oral communication skills
Meeting management/facilitation skills/teamwork
Ability to multi-task is essential
Flexible and able to adapt to company growth and evolving responsibilities

Supervisory Responsibility


Minimum Required Training (optional)


Working Environment

Environment includes working with all levels of internal management and staff as well as with external clients and contractors.

Physical Requirements

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; reach with hands and arms; talk or hear;
climb or balance; stoop, kneel, or crouch. The employee may be required to occasionally lift and/or move up to 15 pounds.

Direct reports

Candidate will oversee QA Associate I, II, and III roles. The QA Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that
are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Keywords: Minaris Regenerative Medicine, Mountain View , Manager, Quality Assurance, Executive , Mountain View, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Hospital Medicine - Hospitalist Medical Director
Description: Hospitalist opening in San Ramon, California. This and other physician jobs brought to you by Envision Physician Services is seeking a hospitalist Site Medical Director to join our team at (more...)
Company: Envision Physician Services
Location: San Ramon
Posted on: 04/19/2021

IT Project Manager
Description: RESPONSIBILITIES:Kforce has a client that is looking for an IT Project Manager for a large Healthcare client in Newark, CA. This is for a migration project from Avaya to Cisco and maintaining all of the (more...)
Company: Kforce Technology Staffing
Location: Newark
Posted on: 04/19/2021

General Manager
Description: Ready to take your management career up a notch If you are passionate about serving customers with an unexpectedly high level of hospitality and quality product while maintaining an extraordinarily clean, (more...)
Company: Denny's - 9523
Location: Gilroy
Posted on: 04/19/2021

Salon Manager - Rivergate Plaza
Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: West Sacramento
Posted on: 04/19/2021

Lab Manager
Description: Yoh Life Sciences is seeking a Lab Manager for a direct hire role with an exciting cutting edge start up focused on gene therapy in South San Francisco. br br br br If this position is of interest (more...)
Company: Yoh, A Day & Zimmermann Company
Location: San Bruno
Posted on: 04/19/2021

REMOTE Global Digital Operations Manager
Description: The role has primary responsibility of digital operational processes, including development, implementation and measurement of digital marketing campaigns. The role will collaborate with cross-functional (more...)
Company: Planet Pharma
Location: Novato
Posted on: 04/19/2021

Associate Data Science Director
Description: Join us on our exciting journey IQVIA is The Human Data Science Company focused on helping our healthcare clients find better solutions for their patients. In Supplier Services we use big data, advanced (more...)
Company: IQVIA
Location: Dublin
Posted on: 04/19/2021

Investigation & Intake Manager (Administrator I)
Description: Job Title: br Investigation Intake Manager Administrator I Description: br Department Name br Office for the Prevention of Harassment Discrimination OPHD br br Salary and Benefits (more...)
Company: The California State University
Location: Rohnert Park
Posted on: 04/19/2021

Chief Financial Officer
Description: If an exciting job opportunity that offers professionally challenging responsibilities, a high level of financial complexity, a collaborative team environment, and the opportunity to live and work in (more...)
Company: Santa Cruz Metro View
Location: Santa Cruz
Posted on: 04/19/2021

Clinic Manager
Description: The Center Manager role coordinates the care and quality of treatments for patients so they can have life, but also a quality of living. The leader in this role conducts proactive planning and creates (more...)
Company: Satellite Healthcare
Location: Rohnert Park
Posted on: 04/19/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Mountain View RSS job feeds