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Site Training Lead

Employer
Pfizer
Location
McPherson, Kansas
Start date
Aug 5, 2022

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Job Details

Why Patients Need You

Oversee and maintain the Training Quality System for the site / location; 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 all colleagues and contingent workers are qualified to perform their GMP responsibilities and that the training is effective.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective Quality Assurance Training team. You will be responsible for leading the site training department and activities involved maintaining a compliant training quality system. Achievement will require a clear understanding of the site training needs, training methods, measurement of training and more.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. It is your managerial skills and hard work that will make Pfizer ready to achieve new milestones and help patients across the globe as well as development of the team and direct reports.

How You Will Achieve It

Maintain a Compliant Training Quality System

  • Develop and update local procedures to comply with PQS Q1228, other PQSs (e.g. Aseptic PQSs) and meet all local regulatory requirements and quality standards.

  • Ensure that all elements of the Training Quality System are maintained compliantly

  • 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.

  • 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 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.

  • 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.

  • 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.

  • Ensure the PLS Site/System Owner is qualified to perform the role of PLS Administrator for the site and that changes to the PLS Site / System Owner role are communicated to the Regional TL&C Lead.

  • 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

  • Liaise with TL&C Regional Training Lead on a regular basis (e.g. monthly), through formal touch-base.

  • Share site training objectives and Annual Training Review (if appropriate) with TL&C Regional Lead.

  • 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

  • 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, education, training and development, instructional design, or related fields; and/or demonstrated equivalent experience with proven success, 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.

  • Qualified M1 Trainer / PHP Facilitator

  • Instructional Design / Adult Learning

  • Leadership experience, minimum of 5 years

  • Experience in auditing with Good Manufacturing Practices {also cGMP} regulated industries required

  • Highly motivated, organized and able to work effectively in a demanding environment with flexibility to changing priorities

  • Strong people management experience

Nice-to-Have

  • Knowledge of pharmaceutical manufacturing and regulatory compliance

  • Knowledge of the site’s Training Quality System

  • Experienced with PLS

  • Experienced trainer / facilitator

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that 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 willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.

  • Must be able to acceptably Don and Qualify for CNC and Grade D/C classified area gowning

  • No standard required travel


Last Date to Apply: 8/12/22

Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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