Job Description

Responsibilities:

Responsible for the quality aspects of good manufacturing practices (GMP) computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations.

Be involved in all quality-related activities for computerized systems which are required by the company manufacturing division Quality Manual or with potential for impact on product quality, patient safety or data integrity.

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.

Conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Collaborate with stakeholders (e.g., System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter Experts) to assess and remediate legacy systems and evaluate/implement new computerized systems, which enable GxP business processes.

Ensure technologies selected meet the high-level business needs while encouraging innovation and efficiency. Interface with Corporate Global IT and other internal & external entities to align GxP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.

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

Provide the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, specifications, 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).

Assure at-site/above-site system owners have Operating Level Procedures/Plans in place, and are routinely followed to ensure that 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 (including sufficiently detailed electronic data review/audit trail review instructions for users), disaster recovery plans, business continuity plans).

Review processes and support documentary evidence to verify that compliance activities related to computerized systems are in place and effective. Support regulatory inspection and audit activities as needed.

Conduct review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local site) and taking appropriate actions to ensure GxP compliance.

Drive resolution of regulatory non-conformance for GxP computerized systems.

Assure monitoring of system health, compliance and other metrics are communicated to key stakeholders.

Promote GxP awareness and a culture of continuous improvement and facilitate manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.

Represent Digital & Data Quality management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.

Contribute to the development and/or maintenance of training programs in the principles of computerized systems validation, computer software assurance, and regulatory requirements in validation, data integrity, ALCOA principles, maintenance, and use of computerized systems.

Provide Quality Unit review/approval of SDLC documentation.

Mentor and provide guidance to junior members of the team.

 

Requirements:

Must possess a Bachelor’s degree in Science, Information Technology, Engineering and at least 5 years of experience in regulated pharmaceutical manufacturing industry.

Must also possess at least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.

Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations also required.

Must possess strong 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; and demonstrated extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.

Must possess familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.

Must be able to perform day-to-day activities with limited supervision.

10% travel (domestic) as needed.

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, Monday - 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”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

01/9/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R319436