Job Description
The Senior Specialist of Quality & Compliance Management is responsible for driving a consistent culture of compliance within the Regulatory Planning & Publishing (RPP) organization within Global Regulatory and Clinical Safety (GRACS). The incumbent works closely with various stakeholders to drive the development of robust and effective Compliance Management Systems within RPP and ensuring adherence to these systems within daily business processes. The incumbent is expected to be skilled in project management with a demonstrated track record of leadership in a cross-functional setting. Additionally, the incumbent may be involved in leading or supporting internal or external process improvement or strategic initiatives.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The responsibilities of the incumbent may include:
In collaboration with the Professional and Organizational Development lead:
- Lead the strategic, organized, systemic approach to training (onboarding/ upskilling) for RPP staff and short-term programs that aligns individual growth with business goals and the employee's development plan, and focuses on creating an agile and flexible workforce.
In collaboration with the Quality and Compliance lead:
- Lead the overall compliance posture of RPP by instituting solid and robust processes and systems that adhere to a regulatory quality and compliance framework.
- Lead all internal and external Compliance audits and Health Authority inspections involving the RPP organization.
- Collaborate with our R&D division's Quality Assurance and GRACS Quality and Compliance on all non-compliance investigations including robust root-cause analysis, ensuring completion of timely and effective corrective and preventative actions (CAPA).
In collaboration with the Process Improvement lead:
- Lead the overall management, direction, coordination, implementation, execution, and completion of RPP projects.
- Manage projects that impact business processes, business development partnerships, and/or information management capabilities throughout the RPP organization. Leverage various methodologies including but not limited to: project management, agile, lean six sigma, design thinking.
- Enhance the infrastructure and processes for a platform from which we can launch comprehensive metrics and reports for project oversight.
Qualifications:
- Bachelor's Degree in a relevant field of study
- Minimum of 3 years of regulatory/safety/compliance experience or minimum of 3 years pharmaceutical experience with emphasis on business process and supporting technology.
- Ability to lead, influence and work effectively in a matrix organization
- Ability to communicate effectively, both verbally and written, with others across levels within the organization
- Effective at establishing clear goals and assigning responsibility in a team setting
- Effective team facilitation with ability to establish collaborative team environments
- Detail oriented and drive overall strategy of projects/programs
Desired Experience, Education & Skills:
- Advanced degree preferred (engineering or scientific discipline, MBA)
- Experience in project management methodologies (e.g., PMP, Sigma, Change Management, etc.) and associated toolsets (e.g., MS Project for project planning, MS Excel and/or PowerApps for data analysis and reporting)
- Experience in quality and compliance systems
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., 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.
Residents of Colorado
Click here to request this role's pay range.
For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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 Know Your Rights
EEOC GINA 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.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$97,680.00 - $153,700.00
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R223308