Manager, Quality Assurance
Company: Minaris Regenerative Medicine
Location: Mountain View
Posted on: April 8, 2021
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
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
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
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
Control Master Batch Records, distribution and label
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
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
Perform employee training on QSR and ISO requirements and company
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
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
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
Strong business acumen
Relevant IT skills (able to work with Visio, Microsoft Project and
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
Minimum Required Training (optional)
Environment includes working with all levels of internal management
and staff as well as with external clients and contractors.
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.
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
Please note this job description is not designed to cover or
contain a comprehensive listing of activities, duties, or
are required of the employee for this job. Duties,
responsibilities, and activities may change at any time with or
Keywords: Minaris Regenerative Medicine, Mountain View , Manager, Quality Assurance, Executive , Mountain View, California
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