Senior Specialist, Quality System Improvement Program Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and 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 an individual 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.
The Senior Specialist, Quality QSIP is responsible/accountable for Quality activities, including execution of Quality System Improvement Program Deployment, which include but are not limited to the following activities:
Assist the site QSIP Lead in project management, including maintenance of the deployment schedule, managing Quality Management System Gap Assessment Team Site and maintenance of completed QMS Gap Assessments in MIDAS.
Assist System and Sub-System owners with the following: gap assessment management, Identifying SOPs and personnel impacted by the revised processes, design and implementation of interim controls as needed until closure of gaps is complete, revise SOPs to reflect requirements of the new standard, Conduct organizational assessments, Design training programs, Implement SOPs as they are developed, Establish metrics to monitor system performance, and Issue written confirmation that the system is in use. Assist with all other applicable Quality functions.
• Requires expertise in own discipline
• Applies knowledge of internal/external business challenges to improve products, processes or services
• Solves complex problems; takes a new perspective using existing solutions
• Works independently, receives minimal guidance
• Acts as a resource for colleagues with less experience within own discipline
• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others
• Applies knowledge of internal/external business challenges to provide input into recommendations for improvements to products, processes or services
• Understands and applies regulatory / compliance requirements relative to their role
The Senior Specialist role will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:
• Executes the Project Plan for QSIP
• Assists in maintenance of QSIP Deployment schedule
• Maintain project plan updates
• Managing status of QMS gap assessments on QMS Gap Assessment Team Site
• Tracks and monitors maintenance of completed QMS Gap Assessments in MIDAS
• Initiate any Change Controls in the GCM TrackWise system that are required for QSIP Deployment
• Assist System and Sub-System owners with gap assessment management, Identifying SOPs and personnel impacted by the revised processes, design and implementation of interim controls as needed until closure of gaps is complete.
• Assist System and Sub-System owners in revision of SOPs to reflect requirements of the new standard, and conducting organizational assessments.
• Assist System and Sub-System owners in design of training programs, assignment of training to the required personnel and implementation of SOPs as they are developed,
• Assist System and Sub-System owners in establishing metrics to monitor system performance and issue written confirmation that the system is in use.
• Assists the Associate Director, QSIP Site Lead in coordination of Regulatory Inspection and Divisional audit activity.
• Tracks and monitors timely completion of all commitments and maintains an evidence file for completed items.
• Provides training and guidance to members of the department
• Manages internal compliance systems to at least include Quality Council and Site Compliance Work Plan.
• Leads project teams ensuring delivery of results against established timelines.
• Manages Quality Risk Management System and Enhancements, per Divisional guidance
• Reviews and approves SOPs for Operations and supporting departments.
• Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of Vaccine & Sterile Operations’ business processes.
• Other duties as requested by management.
• Solves complex problems; takes a new perspective on existing solutions
INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:
• Interprets client and/or customer needs, assesses requirements and identifies solutions to non-standard requests
Influence and Decision Making:
• Explains difficult issues and works to build alignment around a complex situation
• Makes decisions within guidelines and policies which impact a range of standard and non-standard client, customer, operational, project or service activities
• Lead projects as required based upon business needs
• Aware of costs and assists in controlling costs related to own work
• Ability to gown aseptically
• Ability to travel (estimated 25%)
Reports to Associate Director, QSIP Site Lead
Interacts with employees within own department
Frequent interaction with employees from other departments
Interacts with representatives from regulatory agencies
Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
- A minimum of a Bachelor’s
degree (or equivalent degree)
Required Experience and
- Minimum 5 years’
experience in pharmaceutical operations, technical services, and/or quality
operations with at least 4 years in a quality function
- Experience leading a quality
systems implementation project
- Knowledge of GMP
regulations specific to the pharmaceutical industry
- Experience authoring
Standard Operating Procedures (SOPs)
- Experience developing training
Preferred Experience and
- Experience leading organizational change management
- Lean Six Sigma certifications
- A degree focused in Science
- A Master’s degree or
other advanced degree
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. Our Company’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.
If you need an accommodation for the application process please email us
Representatives Please Read Carefully:
Merck & Co., Inc. is
not accepting unsolicited assistance from search firms for this employment
opportunity. Please, no phone calls or emails. All resumes
submitted by search firms to any employee at Merck via email, the Internet or
in any form and/or method without a valid written search agreement in place for
this position will be deemed the sole property of Merck. No fee will be
paid in the event the candidate is hired by Merck as a result of the referral
or through other means.
Visa sponsorship is not
available for this position.
For more information
about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Sr. Spclst, Quality
Primary Location: NA-US-NC-Durham
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
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