Biologics, QA Associate Director

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

Therapeutics Discovery and Development

MD Anderson Cancer Center (MDACC), the largest research-based Cancer Center in the nation, is taking a unique approach in the battle against cancer. It is well-known that MDACC is home to an esteemed academic faculty that cover all aspects of cancer research, publish prolifically in leading journals and present extensively at all major conferences. In addition MD Anderson boasts a vast oncology clinic that runs more clinical trials than any other institution and has created unparalleled capabilities is cell therapy trials. In between the basic science and the translation, MDACC has created a powerful engine driving the future of new targeted, immune- and cell-based therapies: The Therapeutics Discovery and Development (TDD) Division. TDD eliminates the bottlenecks that hamper traditional drug discovery, with a multidisciplinary team of dedicated researchers, doctors, drug developers and scientific experts working together to develop small-molecule drugs, biologics and cellular therapies. Our unique structure and collaborative approach allows the team to work with agility, bringing novel medicines from concept to clinic quickly and efficiently - all under the same roof.

Biologics Product Development

Biologics, be it monoclonal antibodies (mAbs) or cell therapies are complex therapeutics that are revolutionizing the treatment of cancer and yet are difficult to robustly develop and manufacture. To unlock the potential of these modalities MDACC is investing in Biologics Development capabilities within TDD accelerate the results we have already achieved, with multiple programs currently in clinical development. The goal will be to develop industrial biologics with a commercial horizon within the innovative environment of an academic cancer center. The group will be a composite of industry veterans who are interested in applying their experience to develop innovative therapeutics and see them impact patients, as well as academics looking to turn science into products. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. Our unique approach has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.

BIOLOGICS QUALITY ASSURANCE ASSOCIATE DIRECTOR

The Biologics QA Associate Director will lead Quality functions and collaborate cross functionally to ensure compliance with regulations, drive and implement Biologics Developments' compliance directives and support quality management systems to ensure high quality clinical drug product manufacturing. This position will be responsible for the QA oversight of manufacturing and support areas activities, assuring that products are manufactured in compliance with cGMP, USP and FDA guidelines. The role will lead continuous improvement activities of all quality systems and drive a continued state of inspection readiness. The Associate Director will report to the Head of Quality and Regulatory Submissions and be a contributing member of the site leadership team.

RESPONSIBILITIES

• Foster, lead and embed a strong culture of Quality throughout the organization.
• Responsible for compliance oversight of the manufacturing facility and support areas.
• Perform activities to ensure compliance with quality systems, quality procedures, quality policies and applicable regulatory requirements.
• Provide guidance and direct activities to ensure manufacturing facility and support areas comply to applicable regulations and industry best standards.
• Develop and implement best practice quality improvement programs, policies, procedures and processes.
• Actively participate in the development, deployment and maintenance of programs, processes and methods to ensure high quality products and compliance with cGMPs, including investigation/CAPA program management, audit program management, change management, documentation control/practices, records management and continuous improvement to improve quality, reliability, productivity and efficiency.
• Provide QA perspective and final approval for manufacturing investigations. Assure timely review and completion of all investigations. Assure adequate corrective action, commitment tracking, and trending is completed for all investigations.
• Provide deviation/CAPA Management support. Review and approve deviation reports. Mentor investigators and approvers on the investigation process and technical writing.
• Serve as the quality lead in risk assessments, supporting the identification of quality risks and appropriate mitigation plans to achieve compliant solutions.
• Lead and participate in projects within the organizations objectives and project timelines and participate in cross-functional projects as the quality subject matter expert.
• Collaborate with other leaders across the organization and assist in the continuous improvement.
• Lead and support GMP readiness activities for new programs.
• Represent quality assurance at various project and technical meetings, as needed.
• Manage key quality metrics and resources to ensure compliant disposition of materials and cell therapy products.
• Monitor key quality indicators to identify potential risks and for supporting continuous improvement.
• Lead and host inspections for customer and regulatory agencies.
• Coordinate and assist the development of inspection and internal audit responses.
• Prepare and present periodic management updates on Department activities to Leadership.
• Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; including appropriate training and mentoring and development of staff.
• Manage a QA team to provide quality and cGMP input and oversight for all manufacturing related activities through to commercial readiness and ongoing product disposition
• Build collaborative relationships with cross functional areas to facilitate manufacturing operations.
• Other duties as a ssigned.

Education

Required: Bachelor's degree in a related field.

Preferred: Master's degree in a related field.

Experience

Requried: Eleven years of relevant experience to include six years of managerial experience. With Master's degree, nine years of relevant experience to include six years of managerial experience.

Preferred:

• Minimum of 11 years in a quality role in the biopharmaceutical industry. Minimum of six years leading people.
• Knowledge of GMP, FDA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products.
• Strong knowledge of current industry trends and the ability to use the latest technologies.
• Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.
• Strong leadership skills with the ability to thrive in a high throughput environment
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US.
• Demonstrated success establishing and managing QAoperations in a cGMP environment
• Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
• Strong knowledge of biological or cell culture-based manufacturing processes.
• Experience in interacting with health authorities including direct involvement with agency inspections.
• Direct experience in hosting client and regulatory agency audits.
• Direct experience in facility validations and process area start-up activities.
• Influential leader with excellent interpersonal, verbal and written communication skills
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Willingness to think outside of the box, ability to adapt in a constantly evolving environment

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html