Job Description
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will have a key role to play in an organization that has people at its heart. In your role, you will develop, implement and evaluate training programs to provide training effectiveness that will meet the organization's business needs. Your expertise will help in ensuring that the learning and development needs of colleagues are identified, and appropriate programs are design. You will apply current learning and motivation theories, methods and techniques
along with your knowledge of Good Manufacturing Practice (GMP), to improve the effectiveness of the programs and the team.
As a manager, you will oversee and maintain the Training Quality System for the Rochester, MI site; ensure the Training Quality System complies with cGMP standards and corporate quality standards. Partner with site management team to effectively design, develop and implement learning and development programs to support business goals and site strategies and ensure that al colleagues and contingent workers are qualified to perform their GMP responsibilities.provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for products, processes,or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Maintain a Compliant Training Quality System
Develop and update local procedures to comply with PQS standards and meet all local regulatory requirements and quality systems.
Ensure that all elements of the Training Quality System are maintained compliantly, including:
- GMP Training Materials
- GMP Training
- Learning Assessments
- Orientation Training
- Trainers
- Training Curricula
- Training Methodology
- Training Records
- Training System Metrics
Partner with Department Training Facilitators and Department Supervisors and Managers to ensure that training curricula are developed and maintained for all GMP activities and that Training Curricula contain all necessary training for independent performance of the related GMP activities.
Partner with Department Training Facilitators and Department Supervisors and Managers to ensure that Training Curricula are deployed in a timely manner to all colleagues and contingent workers performing GMP activities in the department / area.
Define the process for the control and update of Training Curricula and implement the process for periodic review of Training Curricula.
Define which training topics require periodic retraining/requalification and implement effectively.
Support Department Supervisors to accurately determine their team / colleagues training status prior to assigning GMP tasks to colleagues and contingent workers.
Ensure that effective Orientation Training programs are in place (Basic, Additional, departments / areas).
Ensure that training records are completed appropriately and maintained according to Pfizer record retention policies, including the specific records related to Consultants (if needed).
Ensure that the relevant LMS (Learning Management System) or manual tracking system is properly maintained for training requirements (Curricula) and training records (training history and qualifications).
Ensure that training methodology and the need for a learning assessment is determined via a documented risk analysis and effectively implemented for all SOPs and other GMP training topics.
Ensure that the process for managing learning assessment failures is defined and implemented effectively.
Maintain the training risk analysis documents in a secure folder, separate to the related SOP.
Ensure that ongoing GMP Training is conducted annually, with topics being determined by analyzing relevant needs for the site / location and ensuring that the training is relevant to colleagues’ roles and responsibilities.
Ensure that GMP Training materials are controlled and retained.
Establish and monitor training metrics and drive continuous improvement of the training system. At a minimum, report to SQRT on a 6-month basis the % Completion and Annual GMP Training Progress.
Maintain current knowledge of regulatory requirements and cGMP expectations for training
Act as the interface with auditors and Regulatory Agency inspectors in explaining the Training Quality System.
Where appropriate, lead site training team; coach and develop team members to ensure flexibility of operations and improve engagement and individual development / growth to optimize training skills.
Oversee Site Training Strategy
Develop and communicate site training objectives annually and, where appropriate, conduct an annual review of the site Training System (Annual Training Review) and share with SQRT for endorsement and feedback.
Develop an Annual Training Plan that includes required GMP training, as well as other topics.
Ensure that adequate technical training programs are in place to develop a competent workforce that supports the site quality and performance metrics, and regularly evaluate the effectiveness of these learning and development programs, providing recommendations for improvement.
Partner with site management team and Regional Technical Learning and Capability lead to regularly assess the Training System (Learning System Scale and/ or Training Quality System Assessment) and implement learning solutions to meet site and OpU goals.
Support the Reduction of Learning Related Human Errors
Partner with Quality Investigators when there is a human error Learning Category to ensure appropriate root cause identification and effective CAPA.
Support and contribute to proactive human performance improvement (not just focus on training solutions).
Build Training Knowledge and Skills
Maintain a list of qualified trainers and ensure that an effective Train-the-Trainer process is in place.
Implement effective communication and alignment between Training Coordinators, Department Training Facilitators, and PLS Administrators and support their development.
Ensure instructional design techniques and principles are applied to support GMP, job skills, and procedural training.
Develop innovative communications and opportunities for colleagues to learn and be engaged in the training process and related LMS (e.g. PLS, P2L).
Be a Corporate Training Citizen
Represent the site on Training communications and interactions (e.g. receiving PQS Training notifications).
Receive and actively communicate across the site to ensure the completion of Enterprise Trainings (e.g. Your Reporting Responsibilities, Blue Book, etc.).
Be active in the Learning CoP and related CIGs (e.g. GMP, PLS) with regular attendance at meetings, sharing practices and replicating.
Where OpU or Regional training / learning forums exist, participate fully in representing the site.
Share programs and practices that have network wide applicability and be willing to take on consistent programs and practices to ensure network training effectiveness and efficiency.
Qualifications
Must Have:
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
Experience as Training Facilitator
Experience in auditing with Good Manufacturing Practices {also cGMP} regulated industries required
Don't be allergic to Pencillin.
Preferred Qualifications
Qualified M1 Trainer / PHP Facilitator
Proven needs analysis, instructional design, monitoring, and classroom training skills
Experience developing, delivering and assessing training in both one-on-on and classroom setting
Experience developing and deploying competency-based and computer-based training
Superior organizational and multitasking capabilities
Ability to work effectively with people at all levels of the organization
Supervisory/mentoring skills and experience a plus
Non-Standard Work Schedule, Travel or Environment Requirements
Position requires regular onsite attendance to support 1st shift Site Training with flexibility to support 2nd shift.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performance site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
Must be able to acceptably Don and Qualify for CNC and Grade D/C classified area gowning
Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends.
Some travel may be required on an infrequent basis as well.
Physical/Mental Requirements
Position is exposed to a number of environments, office, lab, outside, plant floor, etc. Must be able to stand for long periods of times during inspectional tours
Position is in a Pencillin facility. Must not be allergic to Pencillin.
Other job details
Last day to apply: November 18th, 2024
Relocation Support available
Employee Referral Bonus eligible
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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