Manager, GMP Training & Development

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.

Role:

Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We started an incredible journey and are looking for passionate leaders to join us on this important mission.

This role is accountable for the management of GMP Training & Development program at the Mississauga manufacturing facility, ensuring that the personnel are knowledgeable, qualified and proficient with the requirements related to their functional role. This role acts as site champion of continuous improvement for GMP training and development program. The role also partners with the corporate GxP Training and Development team and ensures that the site training program complies with the Resilience standards and applicable regulatory requirements.

The Manager, GMP Training & Development program reports to the Head of Quality Systems & Compliance. The position is located at the Mississauga, ON office.

Job Responsibilities:

• Accountable for the management of site GMP Training and Development program

• Manages site personnel training plans and records, and monitors training compliance across the site GMP operations and functions

• Manages New Hire GMP Training at site

• Partners with site management to develop and manage personnel training plans in alignment with training objectives and employee’s functional role

• Manages the Train-the-Trainer program at the site, developing confident, competent qualified trainers with adequate redundancy to support business needs and growth

• Partners with the corporate and network site GMP Training and Development teams to evaluate, test, and recommend continuous improvement initiatives, such as the investment in content development tools, delivery methods, learning technology solutions, and program effectiveness opportunities

• Manages the collection, trending, and maintenance of GMP training metrics which reflect the success of training program and value to the business, utilizing both internal and external benchmarking

• Contributes to periodic Quality Management Reviews, identifies unfavorable trends, and collaborates with functional leads to ensure their timely mitigation

• Participates in Client audits and regulatory inspections as subject matter expert for GMP Training

• Participates in the Resilience network GxP Training and Development Community of Practice

• Creates coaching plans and coaches others to develop their skills and knowledge

Minimum Qualifications:

• Expert knowledge of regulatory requirements pertaining to training in GMP environments

• Knowledge and experience managing GMP Training programs via electronic Learning Management System required, preferably Veeva Vault Training

• Experience interfacing with regulatory authorities and proven record of successfully presenting GMP training programs during inspections are required

• Strong oral and written communication skills with strong technical writing experience

• 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

Preferred Experience:

• Bachelor’s degree in Education/Corporate Training, Instructional Design, Life Sciences, or related field

• Minimum of 10 years of pharmaceutical industry experience, with minimum of 3 years managing a manufacturing facility GMP Training program; experience in biotechnology industry preferred

• Certification as a GMP Trainer preferred

This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement.

Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team. NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources

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