Manager, Quality Systems

Updated: about 16 hours ago
Location: College Station, TEXAS
Job Type: FullTime

Job Title

Manager, Quality Systems

Agency

Texas A&M University Health Science Center

Department

Cnt For Innovation in Adv Dve & Manufacturing

Proposed Minimum Salary

Commensurate

Job Location

College Station, Texas

Job Type

Staff

Job Description


Job Description

What we believe

Texas A&M University is committed to enriching the learning and working environment for all visitors, students, faculty, and staff by promoting a culture that embraces inclusion, diversity, equity, and accountability.  Diverse perspectives, talents and identities are vital to accomplishing our mission and living our core values .”

Who we are

As one of the fastest-growing academic health centers in the nation, the Texas A&M University Health Science Center encompasses five schools and numerous centers and institutes working together to improve health through transformative education, innovative research and team-based health care delivery.

What we want

The Health Science Center (HSC) is looking for an Quality Systems Manager to serve as a member of the Center for Innovation in Advanced Development & Manufacturing (CIADM) team. We desire an individual who subscribes to and supports our commitment as stated above. The successful applicant will bring their experience to the position and understand the demands of supporting the department in a fast-paced environment. This person must be professional, enjoy working in a high-volume environment and be able to apply strong organizational skills while being flexible in their daily routine.  If this is you, we invite you to apply to become a member of our team.


Job Summary: The Manager of Quality Systems is responsible for providing assistance to the Director in areas involving Quality Assurance and Quality Control functions for the manufacture of recombinant proteins, monoclonal antibodies, viral materials, bacteriophages and stem cell materials. This role is responsible for assisting in maintaining the quality management system (QMS) infrastructure and procedures related to the manufacture, packaging, testing, and disposition of drug substances and drug products.

Required Education and Experience:

  • Bachelor's degree

  • Six years of Quality Systems work-related experience in biopharmaceutical or pharmaceutical manufacturing environment.

Required Knowledge, Skills and Abilities:

  • Must have good understanding and working knowledge of cGMP and FDA regulatory requirements as they relate to the production of pharmaceutical products and associated quality assurance and control practices.

  • Self-directed with the ability to multi-task, organize, prioritize and work cooperatively with others.

  • Strong verbal and written communication skills. 

  • Ability to present information clearly and concisely.

  • Computer proficiency with comprehensive working knowledge of MS Office products, minimum.

  • Effective interpersonal and organizational skills.

  • Ability to multi-task and work cooperatively with others.

Preferred Education and Experience:

  • Bachelor’s degree in engineering, life sciences, or similar technical field or equivalent combination of education and experiences.

  • A minimum of seven years of Quality Systems work-related experience in a biopharmaceutical or pharmaceutical manufacturing environment.

  • Experience working with diverse individuals and communities

Responsibilities:

  • Assist in Quality Assurance Control priorities and strategies. 

  • Supports the cGMP manufacturing, testing and release of finished product under FDA standards and internal procedures.

  • Review and interpret regulations and trends and ensure that Quality Systems program proactively address those requirements.

  • Assist in the oversite and review of documentation including but not limited to: change control, SOPs, test methods, validations, protocols/reports, training records, job descriptions, CAPA records, complaint handling, regulatory submission documents, batch records, etc.  

  • Assist in Quality Assurance activities such as audits and regulatory agency inspections ensuring proper documentation and resolution of any issues identified.

  • Assist in regulatory/client inspections and audits, schedule and conduct pre-inspection review of operations where corrective action is required, and ensure documentation is compliant.

  • Assist the Director in the technical/scientific quality matters at the facility. 

  • Qualification of equipment, planned preventive maintenance, calibrations, risk analyses, corrective actions, etc.

  • Ensure the product specifications for in-process drug materials and finished product materials meet regulatory requirements.

  • Review of batch production/history records (Manufacturing and Packaging) for final product disposition.

  • Ensure that key checkpoints for new products and processes are in place and maintained.

  • Additional responsibilities include providing support for applications for new IND drugs (INDs), supporting the R&D/PD project teams and, reviewing CMC Sections for INDs. 

  • Ensure the implementation and oversite of cleanroom activities to ensure compliant behavior and operation of all personnel, essential equipment and air handling services.

  • Ensure all equipment calibration, certification and/or re-certification is completed as scheduled and that external vendors operate in accordance with relevant quality agreements. Investigate all excursions, NCMRs and OOS situations at the facility and implement appropriate corrective/preventive actions.

  • Investigations include non-conforming product, customer complaint, laboratory out-of-specification, and corrective and preventive action(s). 

  • Assist in investigations of product complaints and manufacturing discrepancies and ensure completion of appropriate documentation. 

  • Provide assistance in the review of root cause analysis and other problem-solving activities to identify corrective and preventive actions and appropriate effectiveness measures.

  • Coordinate the preparation, review and approval of annual product quality reports including the compilation of quality data and trends for review by the Director.

  • Performs other duties as assigned.

All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution’s verification of credentials and/or other information required by the institution’s procedures, including the completion of the criminal history check.

Equal Opportunity/Affirmative Action/Veterans/Disability Employer committed to diversity.


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