Merck GxP Consultation Lead in Boston, Massachusetts
New Hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for Covid-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
Information Technology Risk Management and Security Governance Risk and Compliance (ITRMS GRC) is an essential component of the current IT enterprise that supports the Pharmaceutical Research, Supply Chain, and Marketing organizations. The IT Compliance Consultation group is a client-facing service designed to accelerate IT programs by aiding in the navigation and tailoring of the company’s System Development Lifecycle (SDLC). The intent is to simplify compliance for IT through a risk-based approach, integrate automation and digital technology into everything we do, and establish self-service compliance tools.
The Associate Director – GxP Consultation Lead will be responsible for providing regulatory compliance (GxP) advice to IT colleagues regarding the practical application of the SDLC and regulatory controls for GxP IT systems. The ideal candidate is an IT professional with experience operating or validating GxP systems and interacting with Quality Assurance teams in manufacturing and research divisions. This position reports to the Director of IT Compliance & Risk Management.
Provide compliance oversight and advice to IT colleagues regarding the practical application of the SDLC and regulatory controls for GxP IT systems in the manufacturing and research divisions.
Influence decisions and maintain a strong relationship with IT leaders and divisional Quality partners.
Interpret the SDLC, and GxP controls to reduce time-to-production and project compliance documentation.
Provide compliance subject matter expertise for audits and other GxP examination.
Advance Agile SDLC competency for GxP systems.
Lead a team of compliance partners providing consultation services and leadership for the SDLC.
Desired Education Level:
- Bachelor's Degree is required. Concentration in an Information Technology or related field is preferred.
Required Experience and Skills:
8+ years working in IT, Quality or Compliance.
Technical knowledge and understanding of System Development Life Cycle, GxP principles, and computer validation.
Demonstrate an ability to influence decisions and champion policy changes.
Demonstrate an executive presence through good communication and professionalism.
Understanding of emerging technologies used in the IT industry, such as cloud, data science, and analytics platforms.
Preferred Experience and Skills:
Hands-on Agile experience in a regulated industry is a plus.
Experience working with Jira, Confluence, and other Scrum/DevOps tools.
Experience working in a consultation or client-facing role.
Experience with regulated GxP Pharmaceutical IT Systems.
Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
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US and Puerto Rico Residents Only:
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EEOC GINA Supplement
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Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R149823
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