• Job Description

  Req#: R257177

  Job Description

  This is an exciting opportunity for an experienced Quality professional to lead our Digital and Data Quality (DDQ) above site QMS & Enterprise Systems team. The DDQ Associate Director will be responsible for all quality aspects of assigned GMP computerized systems and supporting infrastructure utilized by our Manufacturing Division to ensure compliance with company policies, procedures and regulatory expectations, this includes involvement in all quality-related activities for computerized systems used in support of GMP processes and which are required by our Manufacturing Division's Quality Manual or with potential for impact on product quality, patient safety or data integrity.

  The position will work closely with stakeholders and SMEs from our Manufacturing Division's, Quality operations and IT to provide evidence of quality oversight throughout the computer system lifecycle and must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

  As part of the global DDQ leadership team and reporting to the Director of DDQ, the Associate Director DDQ will be responsible for:

  • Collaborating with stakeholders (e.g., System Owners, Process Owners, Data Owners, and Technical Unit) to assess and select computerized systems which enable GMP business processes.
  • Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
  • Interfacing with our Manufacturing Division IT and other internal & external entities to align GMP shop floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
  • Ensuring a risk-based procedure is implemented and executed to provide the independent quality approval of key qualification/validation documentation to ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle. This includes reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are effective.
  • Providing quality and compliance, Data Integrity consultancy and expertise regarding computerized systems and supporting infrastructure to supported areas, systems, and projects.
  • Leading pre-inspection IT readiness and supporting regulatory inspection and audit activities. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems or infrastructure and taking appropriate actions to ensure GMP compliance.
  • Promoting GMP awareness, innovation, and a culture of continuous improvement regarding IT enabled GMP processes and validation activities
  • Driving results, remaining agile and being prepared

  Minimum Education Requirements and Experience:

  • Bachelor's degree in Science (BS) in Information Technology, Engineering or equivalent with eight (8) years of global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment, OR
  • Master’s degree in Science (MS) in Information Technology, Engineering or equivalent with six (6) years of global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment

  Required Experience and Skills:

  • Minimum 5 years of experience in managing, delivering and/or supporting validated IT, laboratory and/or process automation solutions.
  • Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58, 820, and Data Integrity and local regulatory expectations for assigned areas.
  • Extensive knowledge of the principles, theories, and concepts of computerized system validation/compliance
  • Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching and team building.
  • Experience in leading conversation during regulatory inspections
  • Analytical Problem-solving skills applied to issue identification and resolution.
  • Ability to understand business needs and map to IT technical solutions.
  • Timely decision making
  • Ability to respond to changing priorities.

  Preferred Experience and Skills:

  • Professional Certifications like Six Sigma and/or a certification in project management (PMP) and/or Security Awareness
  • Operate as part of a self-directed team in carrying out day to day functions and assigning priorities.
  • Business engagement skills, with ability to collaborate with both technical and non-technical roles

  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.

  Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

  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.

  We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.

  Learn more about your rights, including under California, Colorado and other US State Acts

  U.S. Hybrid Work Model

  Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

  Under New York City, Colorado State, 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:

  $130,960.00 - $206,200.00

  Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

  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:

  1st - Day

  Valid Driving License:

  No

  Hazardous Material(s):

  n/a

• About the company

  Merck & Co., Inc.,

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