Manager/TL – Training Systems|
Oversee and maintain the Training Quality System for the 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 all colleagues and contingent workers are qualified to perform their GMP responsibilities.
Maintain a Compliant Training Quality System
•Develop and update local procedures to comply with PQS Q1228, other PQSs, and meet all local regulatory requirements and quality standards.
•Ensure that all elements of the Training Quality System are maintained compliantly, including:◦GMP Training Materials
◦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.
•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.
•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.
•Maintain current knowledge of regulatory requirements and cGMP expectations for training
•Act as the interface with auditors and Regulatory Agency inspectors as the SME for the Training Quality System.
•Lead site Training Systems 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.
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 & Requirements
•Bachelor’s Degree in education, training and development, instructional design or related fields; and/or demonstrated equivalent experience with proven success. Previous Managerial Experience, required with a minimum of 5 years experience .Experienced trainer / facilitator, required with a minimum of 5 years experience Knowledge of pharmaceutical/medical device manufacturing and/or regulatory compliance, required Qualified M1 Trainer / PHP Facilitator, preferred Instructional Design / Adult Learning, preferred Experienced with LMS System, preferred
The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit and talk or hear. The noise level in the work environment is usually moderate. The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities include ability to adjust focus.
NON-STANDARD WORK SCHEDULE, TRAVEL OR EVIRONMENT REQUIREMENTS
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary ,short or long term basis.
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.
Travel between Brentwood and Westport locations required.
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.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
You can formally apply at www.pfizercareers.com website by searching Job ID #4774772
Other Job Details:•Last Date to Apply for Job: February 27, 2020
Eligible for Relocation Package: Yes
Eligible for Employee Referral Bonus: Yes