The Affiliate Global Interface (AGI) Training & Development Lead drives the creation and implementation of the training and capability development strategy for the International Quality Management (IQM) team and Local Quality Responsibles (LQRs).
The AGI Training & Development Lead:
· Will work in close collaboration with the AGI/ PDS Liaison Training and Development Lead and other global functions responsible for functional training to ensure that there is an effective training process for GCP/GVP processes in the affiliates.
· Is responsible for developing fit-for-purpose training programs (including on-boarding and continuous education) based on needs identified by regional IQM team.
· Will also oversee the deployment of learning materials and evaluation of course effectiveness.
· Will provide effective learning solutions that are timely and meet the IQM and LQRs needs in line with the defined learning and capability building strategy.
The AGI Training and Development Lead works to optimize and ensure adherence to Quality and Compliance standards through the implementation of learning and capability building strategies for IQM and LQRs.
Collaborating with the PDS counterpart and other colleagues in Quality and Human Resources to support GCP/ GVP compliance and career development for IQM and LQRs, the AGI Training and Development Lead will:
Independently lead, design and implement best-in-class capability building programs for identified needs, based on sound science, process knowledge, regulatory guidance and related controlled documents, as part of the Quality Management System. Support Regional Teams in identifying or creating material to address identified capability gaps for LQRs, and Country Cluster Leads (CCLs). Contribute to the development of global training strategies; ensuring the affiliate needs is satisfied as it relates to the LQRs role. Liaise with LQRs and CCLs and global functions to ensure that there are mechanisms in the global training processes that allow all affiliate staff to be trained on the GCP/GVP landscape documents and expectations. Ensure functional partner expectations for training strategy, materials and deployment are met. In collaboration with PDS Training & Development role, manage the development, delivery and maintenance of a robust induction and orientation program for new starters in the regional or local Quality and PV functions. Maintain the LQR and IQM onboarding programs. Be the IQM, LQR, and non-clinical operations Training Contact for all GCP/GVP training materials. Develop and review quality specific learning plans and role based curriculum for IQM team and LQRs to ensure training packages build consistent levels of comprehension and competency across the intended audience. Lead the delivery and maintenance of the Train-The-Trainer solutions, for the Regional Teams, to successfully extend training expertise and effectiveness. Ensure applied instructional design in the development of training materials and independently manages 3rd party contractors/vendors and internal business stakeholders. Design and implement training mechanism that is locally fit for purpose, including the face to face delivery. Establish, maintain and adhere to style guides and design standards that provide a consistent framework for the development of training materials.
· Advanced degree in Science-related subject or other related field
· Proven experience in the pharmaceutical industry, preferably development and working in a GCP/ GVP regulated area; broad understand of global expectations of Health Authorities in the area of pharmaceutical development
· Worked in or with Affiliates with in depth knowledge of their operations
· Experience in preparation, development and administration of training programs and systems, and training and curricula development
· Substantial organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
· Experienced with a variety of authoring and online learning development tools
· Extensive knowledge of adult/corporate learning, coaching, mentoring and curriculum delivery systems (Learning Management Systems)
· Project management skills
Experience, Skills, Knowledge:
· Advanced knowledge of:
- Global compliance regulations and ICH and GCP/ GVP guidelines
- Pharmaceutical research and development
- Compliance processes and tools
· Successful working experience in:
- Pharmaceutical quality and standards activities
- Utilizing different training and education methods, formats and distribution methods
· Excellent oral and written communications skills
· Fluency in written and spoken English
· Communicates with credibility and confidence
· Interpersonal and stakeholder management skills, including a customer focused approach, and highly effective teamwork and collaboration skills
· Innovative and creative thinker
· Effectively formulates strategies, tactics, and action plans to achieve results
· Ability to extrapolate feedback to assess learning deliverable
· Can work effectively in matrix organizations
· Generates enthusiasm and drive for commitment to excellence
· Willing to travel internationally as needed
In return we offer a competitive salary plus the excellent benefits you would expect from a bluechip organisation, including a genuine interest in your development.
Closing date for applications is Sunday 30th September 2018.
Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance
· Who we are
Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.