Training & Deviation Manager-MAN002124
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position is responsible for managing the training and deviation management team that is responsible for employee training and deviation event investigation during the manufacture of varicella bulk products. Specifically, this role will define and manage the training plans for all employees in the Varicella Bulk Facility (VBF) Operations, lead the investigation to determine root cause, develop corrective actions to prevent reoccurrence, and assess the impact of the deviation on product quality.
Technical leadership will be required to ensure that varicella bulk product and process understanding is sufficient to investigate deviations, that investigations are technically sound and meet quality expectations, and that corrective actions are effective.
More specific responsibilities include, but are not limited to, the following:
- Manage a group of engineers and specialists in training and deviation management for the support of the VBF Operations.
- Use technical knowledge to support operations goals, assuring the right first time and efficient operation of variety of processes, equipment and instrumentation. Areas of responsibility include:
- Responsible for investigation of deviations, with key responsibilities to interface with suite operations, Global Vaccine Technology and Engineering, Automation/IT, and Quality.
- Responsible for managing the investigations to key timing commitments, with well-investigated and well-documented Investigations.
- Work with Operations, the Technology and Quality Approvers to determine the breadth and scope of the investigation to drill to the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition.
- Working with the site Learning and Performance teams and suite teams, develop training plans and monitor the progress.
- Manage and respond to learner needs, ensuring that learning solutions are made available in a timely and effective manner.
- Analyzes and selects the most appropriate strategy, methodologies, and technologies to maximize the learning experience and impact.
- Foster a collaborative relationship with all parties involved by focusing on high quality investigations, meaningful corrective actions and reducing the Investigation generation rate. Determines appropriate Corrective Actions to prevent reoccurrence of deviation. Ensures corrective actions are effective and improve right first time.
- Support achieving investigation metrics for varicella bulk product and process deviations. These metrics include but are not limited to investigation cycle time, number of investigation interims, investigation quality, and number of open investigations.
- Lead and provide direction to a team of investigation engineers and specialists in investigating and proposing solutions. Responsible for providing tactical and strategic direction to improve operations and deviation reductions and ensure achieving Compliance, Supply, Strategic, and Profit Plan goals
- Reports to the coach, Technical and Mechanical Services, working with independent judgment and minimal supervision.
- Maintains an effective organization via appropriate employee involvement, communications, and principle centered leadership. Promotes development and accountability of all employees.
- Establishes clear expectations and objectives to guide area and employees' performance and provides timely feedback, training, and coaching
Bachelor's degree in an engineering area of study is required.
- Minimum of 7 years experience in a manufacturing, technical support, or maintenance engineering role.
- Demonstrated leadership and teamwork skills, experience managing and motivating teams, excellent analytical abilities, proven written and verbal communication skills
- Previous management or project management experience.
- Previous cGMP experience or working knowledge of cGMP.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
- Ten or more years biopharmaceutical manufacturing experience.
- Working Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing.
- Experience in deviation management, investigations, training and project Management
Merck is an equal opportunity employer, M/F/D/V – proudly embracing diversity in all of its manifestations.
Former Military, Transitioning Service Members, National Guard & Reserves - We value your past and present service.
Job: Manuf./Operations Generic
Job Title : Manager
Primary Location: NA-US-NC-Durham
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
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