Director, Data Integrity QMS Topic and KN Owner, Digital and Data Quality

Job Description

Job Description

Position Overview - Basic Functions & Responsibility

Essential function(s) includes, but is not limited to:

The Director of Data Integrity (DI) supports Quality and GMP compliance activities relating to data integrity in the GMP and GDP areas for human health products for firms in the internal network and external network. Collaboration with development groups, Our Company Research Laboratories and external firm quality oversight groups will be required to ensure clear line of sight on DI requirements and deliverables.

The Director will receive direction from the Director and Executive Director of DDQ.

Primary Activities

Primary activities include, but are not limited to:

• Owns the QMS topic for Data Integrity, including the maintenance of associated procedures, and development of new procedures as needed
• Supports activities to ensure Quality Management System Standards reflect agency guidance and expectations on data integrity for GMP and GDP data processes.
• Supports the development of expertise in Laboratory, Manufacturing or other Quality Management System functions and systems related to DI requirements, controls, risk and risk mitigation by owning and running the Company’s-wide Knowledge Network for Data Integrity.
• Provides input to ensure computerized systems and paper systems to meet ALCOA / Data Integrity principles – including interim and long term controls. Supports / provides input into the internal audit program to identify and resolve potential data integrity gaps.
• Provides input to ensure that deviations related to DI are completely and comprehensively addressed. Provide support for on-site execution of DI assessment or remediation activities.
• Partners with relevant groups (e.g. Our Manufacturing divisi / Commercialization / external firm quality oversight groups) to ensure alignment of data integrity requirements.
• Engages in data integrity investigations or initiatives to assure adherence to applicable regulations.
• Partners with relevant groups to ensure that quality systems are in place to enable effective data integrity controls (examples include assessment of systems and data processes, standard work, system standardization, training, playbooks and tools etc).
• Support / lead risk assessments for data integrity controls and remediation. Assist with developing/overseeing development of Data Integrity Training for employees, including initial training, ongoing training and training to address identified gaps/enhancements.
• Provides support to sites in preparation for, during, and in response to regulatory inspections that include data integrity focus.
• Ensures data integrity issues identified by sites or through agency inspections are assessed for network impact and effectively resolved.
• Note: activities are in support of internal or external firms generating GMP or GDP data.

Required Education and Experience:

• BS degree in life science (e.g. Microbiology, Chemistry, Biochemistry), IT or engineering discipline
• 12 years applied professional work experience in pharmaceutical quality, laboratory or manufacturing operations.
• Quality Assurance or Quality Control or IT or Operations experience.
• Strong working knowledge of computerized systems / IT and corresponding business processes
• Understanding of Data Integrity regulations and requirements

Preferred Education/Skills

• Demonstrated management/leadership skills
• Strong skills at team facilitation, team organization and listening.
• Strong collaborative and communication skills to manage teams including ability to communicate effectively in multiple directions.
• Program/ project management skills.
• Strong in-depth understanding of Health Authorities regulatory requirements and compliance/quality requirements, especially as it pertains to data integrity.
• Comprehensive understanding of Quality activities and functions.
• Extensive experience in supporting regulatory inspections and/or performing audits.
• Experience executing Quality Risk Management Tools and principles.
• Training Material development and deployment.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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:

Click here to request this role’s pay range.

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:R203557