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Job Details


Merck & Co, Inc

Director, Global Regulatory Affairs - CMC Operations & Process Support

Operations

Security Operations

No

North Wales, Pennsylvania, United States

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

The Director, Global Regulatory Affairs and Clinical Safety (GRACS)-Chemistry, Manufacturing and Control (CMC) Processes will support design and refinement of CMC processes, systems and procedures to enable effective and compliant CMC support for change control. The Director, CMC Business Process will be responsible for the development/authoring of the CMC processes that support the Health Registration Management System, Labeling and Training systems by partnering with CMC, and our company's Manufacturing Division project team members and stakeholders. The Director will ensure that CMC requirements are defined, communicated, and incorporated into the system design and CMC procedures. The Director will work the CMC Business Process Lead(s) and CMC SME(s) to ensure a successful implementation of the new/enhancements to system(s) by directly contributing to development and approval of procedures, training of CMC users, triaging issues and identifying/implementing compliant solutions. This role will continue to support and processes and will work with CMC colleagues, our company's Research Labs and our Manufacturing Divisions stakeholders on system enhancements and continuous improvement efforts.

The Director will be responsible for monitoring the state of CMC processes and will identify process and procedural updates that will deliver a sustainable level of compliance and process efficiency. The Director will work cross-functionally across all modalities (biotherapeutics, pharmaceuticals and vaccines) in GRACS CMC to identify area-specific needs and/or potential gaps and translate requirements and into integrated, sustainable, and compliant practices. They will be responsible for looking at new innovative ways or working to enhance throughput of work ensuring data quality throughout the process

Requirements:

  • Collaborate with cross-functional and cross-divisional leadership to align shared change management processes into a harmonized CMC end-to-end system functionality that will ensure CMC Processes, efficiency, and effectiveness.

  • Proactively identify and solve the most complex problems that may impact the management and direction of regulatory processes and practices.

  • Collaborate with global stakeholders across multiple disciplines and multiple organizations to develop, adapt and execute regulatory processes strategy.

  • Collaborate and build relationships with stakeholders at the local and global level to leverage diverse experience and align on priorities.

  • Accountable for proactive and timely communication of risks, challenges, and opportunities and addressing them in a systematic and thoughtful manner.

  • Lead/Develop creative and imaginative approaches to solve problems; demonstrate the flexibly to adapt and respond to changing priorities or unexpected events.

Skills:

  • Broad expertise in CMC/regulatory and change management activities across product development, registration, and life-cycle management, as well experience in manufacturing or quality control/quality assurance.

  • Demonstrated ability to anticipate and influence internal/external business and regulatory environment to identify potential changes impacting business practices and proactively recommend process improvements to minimize compliance risk

  • Thorough understanding of external business and global regulatory environment to enable proactive identification of evolving regulatory expectations that may have an impact on the company and regulatory processes strategy.

  • Detail oriented leader with strong leadership, collaboration, and communication skills.

  • Demonstrated ability to interpret and apply diverse regulatory requirements to development of compliant regulatory processes that effectively balance regulatory expectations with business needs.

  • Proven track record in innovative problem solving and rapid, disciplined decision making, critical thinking capabilities, and ability to work well under pressure.

  • Exceptional interpersonal, verbal, and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams.

Position Qualifications:

Education Minimum Requirement:

  • Degree in pharmacy, chemistry, engineering or a related scientific discipline; post-graduate degree preferred.

Required Experience and Skills:

  • Minimum 10 years pharmaceutical industry experience; 7 years with an advanced degree. Minimum 5 years working in Regulatory, including experience in CMC, change management and/or regulatory information management.

  • The candidate must be proficient in English; additional language skills are a plus.

  • The candidate will be required to travel on a periodic basis.

GRACSJOBS

#EligibleforERP

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.

Residents of Colorado

Click here to request this role’s pay range.

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.

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.

Residents of Colorado:

Click here to request this role’s pay range.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R177543