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.
The Director of Compliance for Manufacturing IT will lead the Compliance function within the Manufacturing IT division and deliver programs that mitigate compliance risk to systems and processes, with the goal of enabling continuous inspection readiness.
The Director of Compliance will have accountability in oversight and delivery of IT compliance initiatives, such as the following:
Audit and inspection support impacting IT systems and processes.
Adoption and accountability of the quality manual for those topics that apply to IT.
IT Supplier Management.
IT Compliance Consultation to our IT divisional and site colleagues.
IT divisional investigations and commitments.
The Manufacturing IT Compliance program has touchpoints into numerous initiatives requiring coordination and management which this role will enable through collaboration with all levels of execution and sponsorship at the divisional and site level. This role will operate in alignment with the Manufacturing IT Value Team, Product Line, and PMO Leadership to deliver holistic awareness and advocacy for compliance initiatives, and will coordinate program and project interdependencies, resources, finances, and risk/issue management. The role will require input and direction to the IT System Development Lifecycle (SDLC) through partnership and collaboration with the IT Governance, Risk and Compliance group.
The Director of Compliance must be able to work collaboratively with business, quality and IT colleagues to ensure the success of Manufacturing IT compliance initiatives. This high level of interaction at all levels requires strong collaboration and personal interaction skills. A strong customer service mindset and empathetic awareness of stakeholder needs is imperative to success. The incumbent should bring proactive leadership to a dynamic space, collaborating with and leading teams to deliver significant value opportunities critical to the success of the Manufacturing IT Compliance program.
Bachelor's degree (Preferably in Science, Information Technology, Engineering )
10 + years of working experience in regulated pharmaceutical manufacturing industry
7 + years of working experience in validating IT solutions or in an IT application support role
Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, and 211 and local regulatory expectations.
Previous working experience in the principles, theories and concepts of computerized system validation / compliance.
Previous working experience in a Quality and/or Compliance role in a GMP environment.
Strong understanding of Data Integrity and its application to IT systems.
Previous working experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
Strong interpersonal skills including teamwork, facilitation, communication and the ability to influence.
Preferred Experience and Skills:
Working experience managing direct reports.
Operate as part of a self-directed team in carrying out day-to-day functions and assigning priorities.
Business engagement skills, with ability to collaborate with both technical and non-technical roles.
Experience in leading conversation during regulatory inspections.
Analytical problem-solving skills applied to issue identification and resolution.
Listening, integrating diverse perspectives, adding value to achieve team goals.
Timely decision making.
Project management skills and a proven history producing quality deliverables.
Ability to respond to changing priorities.
Coaching and developing others.
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., Rahway, 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.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
US and Puerto Rico Residents Only:
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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., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.