Specialist, Digital & Data Quality

Job Description

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 interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The essential functions include, but are not limited to:

• The Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
• This includes involvement in quality-related activities for computerized systems which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity.
• The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
• The Specialist DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

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

• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and our Manufacturing Division IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure 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 as needed. This includes the review of audit or inspection reports, responding 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 communicating 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.

Required Education:

• Bachelor's degree required. Preferably in Information Technology, Engineering or equivalent.

Required Experience:

• At least two years of experience in delivering validated IT solutions or an application support role.
• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
• Good understanding 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.
• Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
• Familiarity or 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 Competencies and Skills:

• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
• Hands-on experience in a regulated pharmaceutical manufacturing and/or laboratory environment (Quality or Compliance role in GMP environment desired)
• Good understanding of applicable Laboratory and/ or Engineering Standards related to computerized systems development, implementation & Operations
• Business engagement skills, with ability to collaborate with both technical and non-technical roles
• Multi-lingual capabilities preferred
• Experience supporting regulatory inspections
• Excellent oral and written communication skills including persuading others and developing cross functional relationships
• 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

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., 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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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.

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., 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R211453