What are the responsibilities and job description for the Manager, Quality Management Systems position at Matica Biotechnology, Inc.?

Matica Biotechnology is at the forefront of biopharmaceutical research and development. The Matica Bio team brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products. At our purpose-built GMP facility in College Station, Texas, we provide rapid development and scale-up of cell and gene therapies, vaccines, and Oncolytics meeting worldwide regulatory compliance.

The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We're a cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety and speed of the cell and gene therapy development pathway. Our inventive thinking and foresight help us strategize the best path to take therapies from the lab to the market. Come join our dedicated team and Make it Happen With Matica Bio!

Position Opportunity :

The incumbent is responsible for the management of the Quality Assurance Management Systems. The individual is recognized as a subject matter expert regarding Quality Assurance Management Systems and serves as the main point-of-contact for all audit (internal, client and supplier) related activities. The incumbent is responsible for the oversight of the Quality Assurance Management System, including the Supplier Quality System, Internal and External Audits, Material Release Program and Risk Management Program. Oversight and program management may be required for the Change Control, Deviation and CAPA programs.

The individual initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement. The incumbent makes recommendations regarding capital planning, budget, and standards development. In this role, the individual must be able to identify and communicate improvement opportunities and results. The incumbent identifies operational needs for projects, ensuring site / divisional linkage is achieved. The incumbent must be able to identify and address short term, intermediate, and long-term issues, and be able to appropriately resolve conflict and prioritize work as necessary. This role may have individual contributors and / or temporary support staff reporting to them.

How you will make an impact :

Manages Matica's supplier audit schedule and annual audit planning; tracks supplier complaints and CAPA to closure in a timely manner.
Responsible for and administers the Risk management system and track completion of risk assessments.
Responsible for maintaining and executing Matica's internal audit and client audit program and associated CAPAs.
Assembles critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Leadership on a periodic basis. Track action items for completion.
Aids improvements and process mapping of all supplier quality related processes, updating SOPs and simplifying supplier management tools as needed.
Engages in Materials Management continuous improvements and efficiencies including materials qualification, sampling processes and reduced testing programs; supports client sourced materials / supplier qualifications as needed. Facilitates the process for movement of client sourced materials.
Responsible for all supplier quality audit program / functions and ensuring all requirements are met to approve suppliers.
Perform other duties as assigned.

As a future Matican you bring :

Education :

BS / BA in sciences, preferably in Chemistry, Biochemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, or related technical field.

Experience :

5 years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.

Knowledge :

Working knowledge of :

Supplier Material Release process

Statistical and auditing techniques

Environmental control procedures / equipment

Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell / Gene / Viral therapy products

Ability and experience in turning around and remediating compliance challenges

Strong knowledge of current industry trends and the ability to use the latest technologies

Experience managing / supervising staff preferred

Skills :

Ability to interpret cGMPs and apply to non-routine situations

Demonstrated leadership, technical aptitude, and problem-solving skills

Must be flexible and able to manage and prioritize multiple tasks and assignments

Must have excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.

Demonstrated capability in cross function team environment, working collaboratively with others in effective ways which attain goals while encouraging teamwork and synergies throughout the organization.

Ability to consider the customer's perspective

Capable of high through-put and high quality, Right-First-Time work

Demonstrated subject matter expert in Supplier Management

Ability to make informed and timely decisions independently

Capable of recognizing process gaps and implementing improvements

Ability to delegate

Leadership / supervisory skills

Qualities & Attitude :

Demonstrated leader in the field with sustained performance and accomplishments and a positive, motivating attitude

Excellent work ethic and the ability to work well independently.

Abilities as a team builder, coach, mentor

Diplomatic with strong negotiation skills

Competencies we look for :

Commitment to Excellence, Problem Solving / Decision Making / Analytical Thinking, Communication Skills, Teamwork / Cooperation / Supportiveness, Flexibility / Adaptability, Initiative / Taking Ownership, Focus on Safety, Ethical / Trustworthiness, Work Ethic / Reliability, Thoroughness, Customer Service

We Value :

Matica's Values are at the forefront of everything we do, our culture, and the decisions we make.

Start with Safety & Quality

Choose the Path of Openness, Honesty, and Integrity

Nurture Our Differences to Enable Our Collective Success

Learn Continuously to Ensure Our Value and Relevance

Commit to Delivering Life Altering Therapies

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Manager, Quality Management Systems

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