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Merck Associate Director, Quality Projects Lead in Lansing, Michigan

Job Description

Our Research & Development's Quality Assurance organization is made up of various teams that provide oversight to ensure subject safety and research integrity throughout the drug development life cycle. Our team helps meet the needs of the business and the expectations of customers and regulators by managing risks that may have a meaningful impact on subject safety or research integrity. We do this by developing and driving risk-based strategies to anticipate risks and provide guidance on managing them.​

The mission of the Research & Development's QA organization is to: safeguard the rights and well-being of patients, the welfare of animals, and comply with applicable global regulatory requirements through sound processes and procedures. We provide independent assurance that our company delivers high quality data and clinical supplies.

Description

The Quality Projects Lead will lead our Research and Development divisional QA-driven initiatives that support the Quality Assurance strategic priority of continuous improvement and advancement of the Quality Management System (QMS). The Lead will serve as a QA point-of-contact and IT interface for QA driven initiatives, as well as divisional initiatives that support the QMS infrastructure. Moreover, the lead will be responsible for the project management of technology related projects, as well as, continuous improvement efforts across QA as assigned by leadership.

This individual will be required to work effectively with colleagues across all QA areas to achieve the department’s objectives. The role will communicate information in a clear, concise and timely manner and often will use negotiation, project management, data analytics, and other applicable skills to resolve complex issues. The individual will be able to lead, drive and manage projects that support both the internal projects within Quality Assurance, as well as the collaborative work with our business partners.

Primary Responsibilities

  • Evaluate and evolve quality management system (QMS) infrastructure

  • Support, advance, and drive updates to our Quality Assurance expanded portfolio of systems in collaboration with QA Subject Matter Experts (SMEs): (Veeva Vault QMS, Veeva Vault QualityDocs, and other systems and additional technology tools)

  • Collaborate across QA to continuously improve business processes as it relates to the new systems and tools

  • Support integration of audit resource planning process and tool

  • Working with QA SMEs, evaluate workflows across to identify opportunities to enhance consistency and a streamlined approach to quality

  • Collaborate with our Research and Development Labs IT organization on exploration of technologies to solve QA business needs

  • Lead, understand and participate in the business owner role of System Development Life-Cycle validation activities

  • Collaborate with the QA Analytics & Insights team as needed on the continued evolution of data analytics and use of metrics

  • Understand applicable regulations, technology and processes to work effectively with QA functional areas and subject matter experts

  • Support the development of a Project Management Office (PMO) function within QA

  • Serve as project lead/project manager for activities, which may include (but are not limited to) the following:

  • Drive the development and/or improvement of technology solutions related to document, audit and quality issues management

  • Develop and/or revise standard operating procedures as related to QA systems and supporting practices

  • Participate in continuous process improvement initiatives as related to QA systems and supporting practices

  • Analyzing and trending data

  • Support the development of best practices and resources related to current industry initiatives

Background/Experience

  • Bachelor’s Degree, preferably in a scientific or life sciences discipline.

  • Experience in implementing and adopting new technology and serving as the business interface with IT

  • Three or more years of project management related work in a highly matrixed organization

  • Project Management Professional (PMP) or other project management certifications are a plus

  • Expertise/experience in aspects of Quality Assurance welcome

  • Extensive problem solving and critical thinking skills

  • Excellent communication skills with the ability to tailor messaging to the appropriate audience Ability to identify gaps and recommend improvements to process, driving the associated change

  • Ability to multi-task across numerous high priority projects in a fast-paced environment

  • Ability to work independently and with a team

  • Ability to establish and maintain collaborative partnerships with QA and more broadly to drive consensus

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 …

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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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 (https://survey.sogosurvey.com/r/aCdfqL [survey.sogosurvey.com]) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

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., 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:

Remote Work, Telecommuting, Work Week

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R115182

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