Job Details

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 Senior Manager, Quality Assurance (QA) is responsible for day-to-day management of the Quality Assurance team and is responsible for hiring, managing performance, and development of reporting staff. This role Is recognized as a subject matter expert with regard to Quality Assurance practices and procedures and serves as the main point-of-contact for all QA activities. The Senior Manager, QA is responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, profit plan and strategy objectives of the company and the department. The role initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement. The Senior Manager, QA makes recommendations regarding departmental profit plan, capital planning, budget, and standards development. In this role, the individual must be able to identify and communicate improvement opportunities and results. This role identifies operational needs for projects, ensuring site/divisional linkage is achieved. The Senior Manager, QA 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:

• The Sr. Manager of Quality Assurance is responsible for providing the strategic leadership and management for the Quality Assurance organization.
• Provide leadership to the Quality Assurance organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team.
• Utilize ability to build strong teams, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.
• Implement continuous improvement initiatives to drive Quality Assurance programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
• Develop, implement and monitor Quality programs, policies, and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
• Evaluate Electronic Document Management Systems and processes and recommend and implement appropriate systems to ensure the achievement of long-term objectives.
• Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
• Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent Matica on Quality, Regulatory Affairs, and cGMP compliance issues.
• Responsible for all activities related to the Quality Assurance group including QA on the floor, Quality Operations and Quality Systems.
• Responsible for assuring cGMP requirements are in place at the site and the control, archiving and retrieval of those documents are achieved.
• Direct, develop and evaluate team members to assure all individuals in the Quality Assurance group reach their potential.
• Responsible for coordinating the Quality Assurance Budget.
• Responsible for participation in internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties.
• Responsible for assuring all batches of clinical and commercial material are suitable for use per all applicable cGMP requirements, agency filings, quality agreements and requirement specifications as well as disposition of material.
• Responsible for all supplier quality audit program/functions and ensuring all requirements are met to approve suppliers.
• Other duties as assigned by the Chief Executive Officer.

As a future Matican you bring:

Education:

• BS/BA in sciences, preferably in chemistry, biochemistry, microbiology, biotechnology, pharmaceutical sciences, or related technical field.

Experience:

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

Licenses or Certifications:

• CQA is preferred

Knowledge:

• Working knowledge of:
  • Aseptic practices and clean room operations
  • 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
• Strong knowledge of current industry trends and has the ability to use the latest technologies.

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.
• Demonstrated capability in coaching and development of personnel
• Ability to consider the customer's perspective
• Capable of high through-put and high quality, Right First Time work
• Demonstrated subject matter expert in Quality Assurance
• Ability to make informed and timely decisions independently
• Capable of recognizing process gaps and implementing improvements
• Leadership traits that build and foster trust, respect, cooperation and collaboration across the organization.
• Ability to build strong teams, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict

Qualities & Attitude:

• Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges. Ability to plan and budget at a senior level.
• Diplomacy, negotiation skills, written and oral communication, team building skills, independent work skills, strong work ethic, coaching, delegating 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