Director, Data Integrity

Rahway, NJ, United States

Job Description

The Data Integrity (DI) Champion is responsible for overseeing and ensuring the integrity, accuracy and compliance of data generated within the manufacturing and laboratory processes. This will be possible by delivering the site data integrity strategy and the managing the compliance to our Manufacturing Division DI requirements within the West Point (Pennsylvania) site. The incumbent is also responsible for development of a 3 year site plan, program culture elements, key performance indicators, actions to achieve data integrity maturity at the site, a site communication plan and training content for all employees and contractors at the West Point site. The responsibilities of this role is to ensure sustainment through continuous improvement of the DI Quality Management System and controls at the site. Being the site's data integrity champion will require working alongside SMEs and other data integrity stewards across our Company network to ensure systems are suitable to meet our Company's standards and expectations.

Primary Activities

System owner for the data governance and CGMP/CGDP documentation QMS topic and point of contact for the Data Integrity (DI) COE.

Primary SME for site / function for DI related questions and support. Support development and implementation of DI Global Procedures (GPs)

Point person(s) for coordination and deployment of global DI procedures within the site/functional area.

Management of ongoing DI GEMBA program across site / functional area.

Ensure that data management systems are configured and maintained to meet regulatory requirements and industry standards

Champions the DI mindset and culture on site via a developed program and delivery plan..

Develop and/or deliver training programs on data integrity principles, best practices and regulatory requirements for employees and contractors across site.

Responsible for ensuring site DI governance process is in place and visible from the sites operational areas to site Leadership Teams

Develops and coordinates distribution of DI materials and information across the site / network

Responsible for inspection readiness / inspection responses

Conducts regular reviews and assessments of data integrity risks and implements CAPA as needed.

Single point of contact for integration of Quality Risk Management as it relates to data governance and GMP records

Serves as SME on data integrity matters and provides guidance. Supports site investigations and CAPA identification related to DI events.

Responsible for collection and presentation of DI compliance (metrics), obstacles and challenges to site management, including a review of the DI topic at the Site Quality Council Meeting per the QC standard.

Leads efforts to monitor and audit data processes and systems to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH)

Drives continuous improvement initiatives to enhance data management processes, systems, and capabilities.

Stays current on emerging trends, technologies and regulatory developments related to data integrity in the biotechnology and vaccine industries.

Minimum Required Education and Experience:

Bachelor's degree (BA/BS with eight (8) years applied professional work experience in one of the following pharmaceutical work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT. OR

Master's degree (MA/MS) with six (6) years applied professional work experience in one of the following pharmaceutical work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

Required Experience, Skills, and Knowledge:

Applicable experience, strong understanding and knowledge of Data Integrity expectations in the biotechnology or vaccine industry.

Proven success in delivering strategic data integrity projects.

In-depth knowledge of regulatory requirements and guidelines related to data integrity (e.g. 21 CFR part 11, Annex 11)

Experience with data management systems and software tools (ex. LIMS, ELN)

Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes.

Excellent communication, leadership, and problem-solving skills

Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently

Ability to distill large quantities of data into simple messages and to assess and provide recommendations

Adapts to rapidly changing business needs

Fosters positive, transparent and productive relationships

Proven history of challenging the status quo of business standards and processes with the ability to propose solutions

Proven history of developing strategic plans and implementing on time

Ability to be decisive and influence management with demonstrated leadership skills

Experience in managing cross-functional initiatives or programs

Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)

Preferred Experience and Skills:

Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation) preferred

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.

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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".

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:

Domestic VISA Sponsorship:

No Travel Requirements:

10% Flexible Work Arrangements:

Hybrid Shift:

1st - Day Valid Driving License:

No Hazardous Material(s):

n/a Job Posting End Date:

07/19/2024 *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.

Job Posting End Date: 07/19/2024

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: R299735

PDN-9c5427dc-d369-409d-9178-56dfa5aed34c

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