Senior Specialist, Computer Systems Validation Quality Assurance

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

We are seeking a Growth and Improvement minded Senior Computer Systems Validation Quality Assurance Specialist that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

The Senior Computer Systems Validation (CSV) Quality Assurance Specialist is responsible for ensuring a current, compliant and efficient quality management system for our company's Animal Health IT systems in US and EU Research and Development Division and will continuously pursue system improvements to optimize the IT QA processes in accordance with current regulations and guidelines.

The Senior (CVS) Quality Assurance Specialist will be responsible for providing Quality leadership and support as the Quality Assurance liaison for IT system assessments, validation, change control, process improvements and compliance governance at all applicable points of the System Development Lifecycle (SDLC). This individual will represent Quality on IT projects in support of the SDLC activities, consult on the authoring and conformance of SDLC deliverables and activities in regard to procedures, policies and current regulations, provide QA oversight for system related issues, and employ risk-based methodology. Additionally, the individual will focus on ensuring consistent policy administration, implement key improvement initiatives and solve compliance issues in partnership with business owners.

Key Responsibilities

• Approve SDLC deliverables and activities to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported to support SDLC activities for assigned IT systems, including associated change requests

• Represent Quality Assurance on all assigned IT projects in support of SDLC activities

• Consult on the authoring and conformance of SDLC deliverables and activities in regard to company SOPs, policies and current regulations

• Provide guidance and support to IT personnel in their SDLC efforts, to ensure compliance

• Provide quality assurance oversight for system related issues

• Assist R & D GLP and GCP QA by attending CRO facility inspections to determine if CRO computer systems are 21 CFR Part 11 Compliant

• Act as a high-level technical resource to Quality Assurance and customer base for interpretation of policy, review and approval of technical documents, and high-level decision making

• Employ risk-based methodology, where feasible and achievable

Education

• Bachelor's degree required with a preference in an IT or scientific related discipline

Required

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Five years working in a Quality Assurance IT role

• Knowledge of GAMP5 and OECD Advisory Document No. 17 The Application of GLP Principles to Computerized Systems

• Solid understanding of GxP regulation / guidance, including 21 CFR Part 11, Annex 11 and data integrity

• Experience with Computer System Validation (CSV) across GxP landscape – GLP, GCP and GMP

• Strong communication skills, both verbal and written as well as capable of presenting the right level of information to senior management

• Knowledge of the IT system development life cycle and software Quality Assurance in a regulated environment

• Strong knowledge of software, database, SaaS, concepts for laboratory, manufacturing and information systems

• Ability to work in a very dynamic environment with a clear sense of urgency

• Excellent organizational skills and attention to detail and accuracy

• Pharmaceutical experience

• Principled written and verbal communication skills

• Self-motivated with a high-level of accountability

Preferred

• Experience supporting health authority inspections | Conducting internal audits or vendor audits | Analyst and/or Ennov Clinical or other EDC applications

Travel

• Able to travel up to 25%

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

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.

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:

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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:

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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.

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Requisition ID:R191548