Manager, Quality Management Systems

RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent - investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines, as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:
This role is responsible for the effective implementation and management of the Quality Management System (QMS) and associated business processes at the site and serve as the interface with the global Quality Systems function. The QMS includes, but not limited to, the following programs: Change Control, Deviation, CAPA, Continuous Improvement, Quality Management Review (Quality Council), Quality Risk Management, Annual Product Review, Site Master File, and Quality Metrics. This function supports the site’s cGMP compliance with government and health authority requirements, as well as meeting client expectations.

MAJOR RESPONSIBILITIES:

- Serve as the site Business Process Owner for QMS modules of Deviations, CAPA, and Change Control
- Manages team members within the Quality Systems QMS function
- Ensures the effective implementation of the global Quality Management System at the site, including transition from and decommissioning of legacy systems
- Monitors related QMS metrics, reports status, and recommends action to maintain a functional QMS across site and system roles
- Review & approval of related Quality Systems documentation (Deviation, CAPA and Continuous Improvement, Risk Management, Annual Product Review, etc.)
- Escalates to senior management Critical Quality and Compliance events
- Partners with Operations and Development teams to assist in implementing and maintaining effective, risk based GMP processes, procedures, and documentation.
- Supports and drives continuous improvement initiatives; identify, analyze and monitor related metrics, and promote a Quality Culture
- Recruit, coach, mentor, and develop personnel
- Responsible for maintaining team’s GMP training assignments in a compliant status
- Assist with preparation of departmental budget, monitor and control spending
- Additional responsibilities in accordance with business needs

MINIMUM QUALIFICATIONS:
TECHNICAL KNOWLEDGE / EXPERIENCE
- Advanced knowledge of quality and regulatory requirements pertaining to GMP Drug Substance and sterile Drug Product manufacturing
- Technical knowledge of facilities, equipment, lab instrumentation and methods
- Practical experience in Root Cause Analysis techniques, Risk Assessment tools, Investigation methodologies, Human Performance, and Continuous Improvement programs
- Experience interfacing with regulatory authorities and proven record of successfully presenting Quality processes during inspections
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment
- Proven ability to work as part of a well-integrated, networked team, and effectively collaborate across functional, organizational, and location boundaries
- Demonstrated strong skills in leadership, decision making, risk management, continuous improvement and problem solving
- Strong interpersonal, verbal and written communication skills

PREFERRED QUALIFICATIONS / EXPERIENCE:

- Bachelor’s degree in science with a major in Life Sciences, Chemistry or related field
- Minimum of 7 years of pharmaceutical industry experience
- Minimum of 5 years of leadership experience, including managing GMP Operations and/or Quality Operations teams

BEHAVIOURAL:
Teamwork: Working effectively and productively with others

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

Problem Solving: Anticipating, analyzing, diagnosing and resolving problems

Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives

Decision Making: Utilizing effective processes to make timely decisions

Conflict resolution - Effectively broker solutions to resolve conflicts between individuals and groups.
- This job profile provides an overview of the minim