Job Description

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Under the leadership and directional guidance of the Director, Audits & Inspections who drives and supports the development and implementation of strategies and initiatives to maintain and advance the Research & Development (R&D) Quality Management System (QMS).

The Associate Director will support activities related to audits and health authority inspections for the various R&D functions related GXPs and will partner with cross-functional Leads to ensure the achievement of quality goals. Assignments are complex and require detailed understanding of regulations and processes to minimize and mitigate risks.

Primary Activities:

Independently supports departmental operational activities utilizing advanced competencies, knowledge, and judgment; proactively identifies and resolves complex issues. Facilitate on-site audits and health authority inspections Supports the global audit and inspection readiness program and CAPA management. Support the Director in establishing and maintain a compliance governance structure providing metrics review of key quality & compliance activities and to prioritize and ensure ad hoc topics/emerging are reviewed and escalated in a timely manner Support the collection of quality and compliance metrics and quality dashboards intelligence Execute the audit strategy including internal process audits and audits of external business partners Interface and provides day-to-day quality and compliance support to the functional areas Analyze and leverage quality indicators and data to identify potential trends and risks Support functional areas in assessment of potential root causes and remediation (corrective and preventative actions) and effectiveness checks Strong verbal skills and experienced effective writing skills in the area of investigation and deviation reports which include root cause analysis, impact assessment, corrective and preventative actions Acts as a strong technical resource and is called upon to assist in issues based on knowledge of relevant Standard Operating Procedures and GXP regulations. Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, Good Clinical Practice,), safety guidelines and company policies and procedures. Collaborates effectively across areas within R&D and partnering organizations to achieve quality goals and understanding of and application of appropriate regulations in partnering areas. Provides inspection management support as needed. Inspection experience a plus. May develop, contribute to, or lead educational and training materials and sessions to further develop competencies or process understanding across R&D functional areas, where applicable.

Primary skills include but are not limited to:

Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.

Communication Skills: Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills.

Problem Solving: Demonstrates expert level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.

Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within quality or across areas within R&D that improve quality and /or add value to the business.

Project Management: Demonstrates expert ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.

Decision Making: Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.

Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure the functional areas within R&D are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

Educations/Experience:

BS/BA degree in relevant field (Pharma/Science/Engineering) area with

* Minimum 10 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GXP Quality and regulatory requirements

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.

NEWCO

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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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

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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:

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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 anothers 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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R107412