Back

Associate Director, Third Party Quality Management, Analytical Testing

Merck Cherokee

Location Pin Icon
Rahway, NJ
LOCATION

Job Description

As posted by the hiring company

Job Overview:

Job Description

The incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company. Key activities this position would be responsible for include: leading internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, maintenance and accuracy of the Development Approved Vendor Listing, participating in contractor GMP audits as a Subject Matter Expert, development and creation of contractor related metrics, conduct of contractor “deep dive” quality assessments such in data integrity and guiding cross-functional contractor performance reviews as the quality lead for the oversight platform.

The position will be heavily involved in close collaboration with the contractor quality and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including GMP qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between R&D and Commercialization activities and develop a strong working relationship with commercial external quality management personnel. The incumbents would be the key quality representatives attending and contributing at oversight and business review meetings with our Company and contractor personnel to discuss projects, financial, operational/quality and overall performance topics.

In addition to the job specific responsibilities discussed above, the position is expected to execute on the following:

  • Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision

  • Provides project management in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment.)

  • Leads Quality-related reviews, cross-functional process teams and/ or investigations, serving as a subject matter expert

  • Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities

  • Makes independent decisions and acts with authority to carry out actions needed

  • Coaches, mentors and develops colleagues in areas of expertise. Leads others in a matrix/management environment

  • Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity. on cross-functional and/ or cross-divisional basis

  • Identifies trends and/or potential compliance gaps and proactively steers the resolution of long-standing or significant issues affecting quality and efficiency.

  • Leads communication, and serves as Quality spokesperson, on a variety of Quality or compliance-related issues.

  • Interprets complex regulatory requirements for various audiences, including source area management, and facilitates communication of these across stakeholders. Reviews draft policy and standards.

  • Communicates with senior management within our Company and the contractor organization. Facilitates and/or prepares cross-functional management presentations.

  • Identifies and leads implementation of Contractor and Supplier System improvements

Education:
  • Bachelor Degree in Chemistry, Biology, Engineering or related field

Required Experience and Skills:

  • At least 10 years of relevant experience within the pharmaceutical industry or 8+ years with advanced education.

  • Strong scientific/ technical expertise in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues relating to Analytical Testing.

  • Flexibility to travel up to 20% both domestic and international.

Preferred Experience and Skills:

  • Strong compliance knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment

  • Strong understanding of regulatory agency regulations and requirements

  • Background in Vaccine and/or Biologics method development, characterization, technology transfer, and release

  • Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives

  • Ability to independently interact with regulatory officials and external auditing parties

  • Possess deep drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process

  • Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation

  • Strategic view of project issues in a Quality Systems environment

  • Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills

  • Demonstrated skills in communicating (oral and written) effectively with diverse people/groups

  • Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise

  • Demonstrated skills in: operational planning (3 months to 1 year span); integrating, managing, and/or coordinating similar/ related teams, units, work processes or functions

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Flex Time, Hybrid

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1