Associate Director, R&D Compliance Operations

Job Description

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 customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.

The Global Clinical Supply Compliance Operations Manager is accountable for leading a team of our company and non-company staff to ensure compliant processing of day-to-day activities as described below. There is opportunity to have a meaningful impact on the clinical supply chain operations by means of process innovation, compliance adherence, and team development. This will include managing the team to develop and implement processes and procedures to ensure compliance with applicable internal policies, regulations and laws.

Position will work with Quality Assurance, Global Trade Compliance (GTC), GCS and our company's Regional Leads, site shipping personnel, Clinical, and Research stakeholders across all global company locations. Position will also interact with Logistics, Clinical Country Operations, and external vendors/shippers. Key challenges will include managing and enabling a team to influence all colleagues and stakeholders to following GMP and global trade policy and procedures along with solving supply specific issues when they arise.

Key Responsibilities Include:

• Manage a team to ensure shipments are cleared quickly and compliantly through Customs and other government/regulatory agencies including ensuring the appropriate permits/licenses are applied and obtained.

• Support a team responsible for executing day-to-day operations for administration of compliance systems:

  • processing of Learning management system requests

  • administration and tracking of documents (e.g. SOPs, GMP and Trade Compliance Standard Business Practices) in electronic document management systems

  • collation & generation of compliance metrics

  • processing access requests for SAP and Global Trade system.

  • tracking compliance commitments

  • audit system data entry of responses/CAPAs.

  • audit/inspection preparation and logistics support

• Manage and enable a team to identify opportunities for compliance process improvements within Global Clinical Supply and interface with stakeholder groups such as our Research Division, Quality, Learning and Development, Global Clinical Trial Operations, Global Trade Compliance, and research areas of DPED.

• Ensure compliance with GMP quality standards and procedures, global trade regulations and Global Trade Compliance global standards as applies to all processes, sites and resources.

• Support the GCS global GMP footprint and our Research Division Trade Compliance Ops Global footprint including support to deploy our company's Compliance strategic goals and objectives aligned closely with business objectives.

• Partners with area SMEs across the company on initiatives, as appropriate.

• Work with area leads and subject matter exports to assess performance to drive continuous improvement as well as identifying new opportunities seeking input from key stakeholders

Education:

• Bachelor’s degree in science or pharmaceutical science

• An MBA or other business degree is beneficial

Preferred Experience and Skills:

• At least 10 years’ experience in the pharmaceutical industry along with functional knowledge in GxP and Trade Compliance

• At least 5 years of experience managing people and leading teams

• Understanding of Customs and GMP regulations

• Prior experience with SAP, Microsoft products, compliance systems- training, documentation, Trackwise, Spotfire or other metrics tools.

• Good project management skills along with ability to organize and manage multiple tasks at one time and meet deadlines

• Strong verbal and written communication skills

• Demonstrated leadership and management experience working with cross-functional teams on complex projects

• Awareness of Diversity and Inclusion

GCSCareer

VETJOBS

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R169251