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Director, IT Quality

Merck


Location:
West Point, PA
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
QUA006126
Merck
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Job Details

Job Title: Director, IT Quality  - QUA006126

Description

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 

 

Responsible for management of the MMD Global Computer & Automation Systems Validation Quality group. Provides regulatory oversight and an independent role in the approval or audit of key documentation such as policies, procedures, acceptance criteria, plans, reports, approval of changes to GMP computerized systems that potentially affect patient safety, product quality, or data integrity, and audits processes and supporting documentary evidence to verify that compliance activities are effective.


Provides IT consulting and guidance to IT groups looking for regulatory solutions. This at times will include looking for opportunities to reach out beyond the department’s scope to actively seek out opportunities to leverage strategies that are effective and efficient. In addition this position will actively seek out teaming opportunities with other parts of the business to drive consistency and a harmonized approach to system development, compliant validation strategies, and a consistent understanding of Merck’s approach to IT solutions.


Responsible for the management of IT sections of the Quality Manual (QM), Quality Management System (QMS) Computerized Systems Validation Chapter and all related documentation, web sites and training materials for IT Compliance.


Develop and manage risk based strategies to provide efficient and effective validation of regulated IT systems. This will require a deep understanding of the MMD System Development Life Cycle (SDLC), GAMP 4 & 5, PIC/s, 21 CFR Part, 211, 820, 11, Annex 11 and developing and future regulations.


Act as the liaison between IT QA and IT groups, business functions that develop and use enterprise technology. This will include the collaboration of MRL, MMD, Human Health, Animal Health, subsidiaries, strategic partners and vendors. This will at times include support at the site level.


Managing Multiple/Large IT validation work streams at the same time.


Responsible for Quality Projects as assigned by the Executive Director for IT Compliance.


As assigned by the Executive Director for IT Compliance, responsible for Regulated IT Systems that require remediation. This could include Contract Manufacturing Organizations and Strategic Partners involving multiple weeks of working on site often in a ex US setting.


Responsible for the management of IT Compliance staff, including Human Resource activities, training of staff, assuring that staff members are kept current on IT Training for new technologies, applications and regulation.


The ability to adapt and maneuver through a rapidly changing environment

Essential Functions


1 Has managed the deployment of large validated Enterprise Systems within a GxP


2 Provides the Quality oversight to the validation of centrally installed and supported GMP computerized systems used by multiple MMD sites and other Merck Divisions (e.g., MRL, Merck Information Technology). This includes the review and approval of :
• Validation (Quality) Planning,
• Quality Risk Management assessments and plans addressing patient safety, data integrity and product quality.
• Release of the systems for use
• System requirements
• Systems qualification and verification
• Validation summary
• Deviations and CAPAs
• Retirement and decommissioning
• Procedures related to System use and maintain a validated state


4 Provides the management of the individuals representing the regulatory required inputs and direction to the validation of centrally installed and supported GMP computerized systems used by multiple MMD sites and other Merck Divisions (e.g., MRL, Merck Information Technology). This includes

• The review and approval of :system validation documentation
o Validation (Quality) Planning,
o Quality Risk Management assessments and plans addressing patient safety, data integrity and product quality.
o Release of the systems for use
o System requirements
o Systems qualification and verification
o Validation summary
o Deviations and CAPAs
o Retirement and decommissioning
o Performance Monitoring and Periodic Reviews
o Procedures related to System use and maintaining a validated state
• ensuring that SOPs required for maintenance of the system exist and are followed
• ensuring adequate training for maintenance and support staff
• ensuring changes are managed
• ensuring the availability of information for the system inventory and configuration management
• reviewing audit reports, responding to findings, and taking appropriate actions to ensure GxP compliance
• coordinating input from site process SMEs and users)
• develop/review of business case documentation for system improvements, upgrades

 

5 Seek out external opportunities to influence industry practices and regulations specific to validation. Provide guidance and SME expertise for preparation of internal and external regulatory observations.


6 Oversees, participates and approves the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units.



Qualifications

Education Minimum Requirement:

  • A minimum of a B.S. or B.A. in Engineering, Science, or Information Systems, or related relevant discipline. 
  • Advanced Degree is preferred.

Required Experience and Skills:

  • A minimum of 10 years of manufacturing and/or quality operation management experience within an FDA and/or EU pharmaceutical, device and biologics environment.
  • Prior Site and Global Quality experience in FDA and/or EU regulated pharmaceutical, vaccine, biologics, API manufacturing is required.  
  • Experience in laboratory, manufacturing, information/automation systems, or technical support, and interpretation and application of GMP Validation expectations. Must have strong analytical skills in order to develop and recognize appropriate action plans and how they will impact operations and compliance.
  • Established ability to provide feedback and coaching in a constructive manner to help others complete System Life Cycle validation projects in accordance with cGMP and Quality Risk Management principles.
  • Experience evaluating software and hardware requirements, and making decisions related to the system selection and support process.
  • Hands on experience with computer validation in a GMP environment.
  • Experience managing the validated deployment of GMP Enterprise Systems.
  • Direct experience with regulatory audits.
  • Excellent communication, negotiation, facilitation and influencing skills. Demonstrated leadership in achieving shared objectives within a highly matrixed organization, participating in cross-divisional projects and building effective cross-functional relationships
  • Lean Six Sigma belt certified preferred.
  • Demonstrated ability to establish and maintain relationships to ensure continuous progress and productivity. Established understanding of issues relevant to organization, business, and competitive/economic environment.
  • Plays as a significant team member or team leader on cross functional/large complex team and has influence on team decisions.
  • Thorough understanding of Quality Management Systems for drugs, devices, biologics including risk management.
  • Energy, self-motivated, proactive and endurance to stay focused on the task at hand and thrives on the challenge.
  • Adaptable to a fast paced, complex and ever changing business environment, flexible, proactive and decisive
  • Model and reinforce behaviors consistent with Merck's Leadership behaviors, values and culture.
  • Attend industry related conferences to stay current with regulator expectations and requirements. Travel to manage remote staff, attend required internal or external divisional, staff or other meetings.
  • Position will be primarily based out of Merck facility in the US.  

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm 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:

 
            
            




Job Qual Assurance & Ops Generic

Primary Location NA-US-PA-West Point

Other Locations NA-US-North Carolina, NA-US-Virginia, NA-US-Texas, NA-US-Pennsylvania, NA-United States, NA-US-New Jersey

Employee Status Regular

Number Of Openings 1

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