Associate Director, QC

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Job description

Associate Director, Quality Control

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

The Associate Director, Quality Control is a ccountable for the leadership activities and directing all aspects of the Quality Control laboratory activities, including but not limited to: scheduling, testing, documentation, inventory management, training, method qualification/validation, equipment management, Certificate of Analysis generation, QC data trending analysis, GLP and cGMP compliance, interaction with clients and regulatory agencies. Responsible for building and/or implementing effective laboratory systems, processes, teams, and managing the staff to overcome the daily challenges of our business.

Essential Functions And Responsibilities

Manage the day-to-day operation of the QC Laboratories (BioAssay and Microbiology)

Prioritize workloads and testing schedules to meet client and manufacturing requirements.

Assure that laboratory instrumentation is properly qualified per GMP and where required, is GMP/Part 11 compliant.

Working with Development as required, develop and qualify new test methods.

Assure that existing methods used in the QC Laboratories in Mountain View are properly qualified.

Assure consistency in the choice and implementation of test methods and interpretation of test data within and across the site.

Assure efficiency in data review and documentation.

Working with the QC Leads in Allendale, NJ and/or Mountain View, CA, along with other stakeholders, implement a Laboratory Information Management System (LIMS) and electronic system for managing environmental monitoring data.

Working with MSAT in Allendale and Mountain View along with Operations and other stakeholders, manage Technology Transfer including but not limited to:

Writing/reviewing/approving of transfer documents

Methods transfer from Development to QC

Methods transfer between sites

Process transfer, as required

Working with Manufacturing Operations and Development at both sites, provide support for process verification/comparability/qualification/validation documents as required.

Working with the Training Group, develop proficiency training for laboratory analysts.

Develop, assess, and report on metrics for Quality Control including but not limited to

Environmental Monitoring

Out of specification results

Invalid test results

Hire, develop, train, and evaluate QC personnel.

Monitor effectiveness of the quality systems (change control activities, deviations and CAPA) for completion of both site and client specific.

Evaluate and investigate customer complaints and deviations, initiate and coordinate corrective and preventive actions as they relate to the quality control function or as assigned.

Oversees documentation and implementation of the quality system to assure compliance with customer, regulatory requirements and company standards

Reduces non-conformities and non-value added processes

Inspires continuous improvement through employee empowerment

Develops and implements cost reduction programs

Develops short and long term strategic plans

Manage third party testing labs

Review and approve invoices for reconciliation NetSuite.

Qualifications

Bachelor's degree in Life Sciences or equivalent, advanced scientific degree desirable

Minimum of ten (10) years relevant experience in Quality Control

Minimum Of Five (5) Years Of Leadership/supervisory Experience

Previous experience interacting with FDA Investigators and other Regulatory agencies

Previous experience with management of QC Laboratories

Understanding of Technology Transfer and method validation

Understanding of laboratory instrumentation including: Part 11 compliance,

Understanding of and experience with analytical tests and assays used for cell/gene therapy testing including but not limited to Flow Cytometry, cell counting methodologies, safety testing (sterility, endotoxin, mycoplasma)

Understanding of lean six sigma principles

Clear understanding of compliance regulations 21 CFR 211, 21 CFR 610, 21 CFR 1271, 21 CFR 11, EU Annex 1; FACT Standards; ISO standards as appropriate

Competencies/Candidate Profile

Strong business acumen

Relevant IT skills (able to work with Outlook, 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 team is essential

Flexible and able to adapt to company growth and evolving responsibilities

Ability to manage ever-changing client and business needs by prioritizing, scheduling and delegating tasks, resolve inefficiencies, and re-allocate resources within the confines of the Quality System

Creative and compliant thinking for simplification of laboratory processes and paperwork

Good inward/outward facing written and oral communication skills

Supervisory Responsibility

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving.

Directly supervises employees within the Quality Control

Minimum Required Training

N/A

Working Environment

Must have the ability to work in a team-oriented environment and with clients

Must be able to work during the weekend, holidays and as required by the company

May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen

Must be able to handle the standard/moderate noise of the manufacturing facility

Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.

This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear, balance; stoop, kneel, or crouch.

This role is sedentary. An individual may exert up to 50 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods of time.

Direct reports

QC Associates

QC Scientist

Microbiology Supervisor

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.

Monday-Friday, Day Shift--8AM-5PM