Organon - Quality Assurance IT Director - #156052

Merck & Co., Inc.


Date: 02/23/2021 07:00 AM

City: Lansdale, Pennsylvania

Contract type: Full Time

Work schedule: Full Day

Job Description


The Director, Quality IT, position will be responsible for leading a team for the oversite of Quality aspects for GxP systems. The candidate will lead activities/projects supporting the strategic and operational alignment, cooperation, and communication across Organon functions and be a key contributor to the development of behaviors and practices that foster a culture of accountability and excellence in Quality. The candidate will be a key contributor to the development and execution of continuous improvement initiatives, development of strategic methodologies, and best practices for compliant systems and tools.


The candidate will drive initiatives within the management team and organizationally that contribute to long-term operational excellence and a shared vision of the Global Quality and Compliance (GQC) organization.


Main Activities:



  • Responsible for management of a 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 our Company'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 Compliance and IT groups, business functions that develop and use enterprise technology. This will include the collaboration across organizations and sites and with strategic partners and vendors.

THIS IS A REMOTE POSITION


Skills:


Education Minimum Requirement:



  • B.S or B.A – In Science, Pharmacy, Computer Science, Engineering Or A.A. or A.S. In Science, Pharmacy, Computer Science, Engineering with at least 20 years of industry experience

Required Experience and Skills:



  • Minimum of 10 years of experience in regulated Pharma, BioTech, Vaccine or Device Manufacturing or Research.


  • Proven ability to analyze and lead others to transform complex systems to deliver significant-quality, cost, delivery, and lead time benefits


  • Experience analyzing complex end-to-end processes and driving process improvements


  • Hands-on application of Lean tools and techniques: standardized work, scientific problem solving, value stream mapping, mistake proofing, etc.


  • Experience applying consultative skills: ability to influence, ability to interact with all levels of the business (senior leaders to shop floor working teams), project management skills, solid business acumen, proven team-building skills, exceptionally good listening skills, results-oriented, strong analytical skills, and prior process improvement experience.


  • Proven experience coaching and teaching others. Experience enabling and leveraging diverse perspectives, talents, etc. to achieve business outcomes.

Preferred Experience and Skills:



  • Excellent skills using IT applications to organize and analyze data


  • Experience in operations management, manufacturing, laboratory supervision or related disciplines

Who we are …


Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.


Our Vision is clear: A better and healthier every day for every woman.


At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.


At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.


NOTICE FOR INTERNAL APPLICANTS


In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.


If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.


US and Puerto Rico Residents Only:


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


For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster


EEOC GINA Supplement


OFCCP EEO Supplement


OFCCP Pay Transparency Rule


We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Search Firm Representatives Please Read Carefully


Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.


Employee Status:


Regular


Relocation:


Domestic


VISA Sponsorship:


No


Travel Requirements:


25%


Flexible Work Arrangements:


Remote Work, Telecommuting, Work Week


Shift:


Valid Driving License:


No


Hazardous Material(s):


Number of Openings:


1

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