Senior Specialist, Digital & Data Quality Assurance - Information Technology

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Senior Specialist, DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients and will report to the Associate Director of Quality, DDQ or higher.

Responsibilities

Collaboration (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 Manufacturing Division (MD) IT and other internal and external entities to align GMP shop-floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives

• Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work

• Providing the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations)

• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans)

• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective

• Supporting regulatory inspection and audit activities, which includes the review of audit or inspection reports, replying to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance

• Driving resolution of regulatory non-conformance for GMP computerized systems

• Monitoring and conveying system health, compliance and other metrics updates to key stakeholders

• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices

• Representing DDQ management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues

• Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems

• Mentoring, training and providing day to day technical/compliance guidance to DDQ Specialist

Education

• Bachelor's degree, preferably in Science, Information Technology, Engineering or equivalent

Required

• Direct experience and comprehension of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations

• Minimum five years in regulated pharmaceutical manufacturing industry

• Minimum three years delivering validated IT solutions or an application support role in a regulated environment

• Strong comprehension of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations

• Extensive knowledge of the principles, theories and concepts of computerized system validation/compliance

• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment

• Limited supervision required in day-to-day activities

Preferred

• Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP)

• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities

• Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations

• Direct experience in a Quality and/or Compliance role in a GMP environment

• Business engagement skills, with ability to partner with both technical and non-technical roles

• Multi-lingual capabilities

• Leading conversation during regulatory inspections

• Principled verbal and written communication skills including persuading others and developing cross functional relationships both at site and across sites

• Analytical Problem solving skills applied to issue identification and resolution

• Listening, integrating diverse perspectives, adds value to the achievement of team goals

• Timely decision making

• Project management skills combined with a since of urgency and a proven history producing quality deliverables

• Ability to respond to changing priorities

• Inclusion behaviors

• Coach and provide technical/compliance guidance to others

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

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 …

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.

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

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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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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Requisition ID:R142253