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Associate Director, Data Integrity
2 months ago
Job Description
The Data Integrity (DI) Champion is responsible for management of the strategy and oversight of the implementation of our Manufacturing Division DI requirements within the site. The responsibilities of this role are to lead and facilitate the implementation and sustainment of the DI Quality Management System and controls at the site. Additionally serve as a champion to promote a healthy Data Integrity Culture within the site by ensuring oversight, training and communication with the site operations.
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 (workshops, document reviews, pilots, deployment, and implementation)
- Point person(s) for coordination and deployment of global procedures within the site/functional area.
- Implementation of ongoing DI GEMBA program within site / functional area. Ensures new systems/processes/procedures are compliant to DI GPs and WIs, in conjunction with lab, IT, SF automation partners and QA IT Collaborates with IT, Operations and Quality site capital program leads to track DI remediation progress for reporting through Ops, Quality, and QMS tiers Champions the DI mindset and culture on site and influences all employees via appropriate methods in this regard.
- Responsible for ensuring Site DI governance process is in place and visible from the sites operational areas to site Leadership Teams (either thru integrated DI tiers or established site governance meetings Active participant in DI Knowledge Management Forum / Community of Practice Distribution of DI information within the site / functional area, and from the site / functional area to the DI COE Supports site for DI Inspection Readiness / Inspection Responses for DI Point person for integration of Quality Risk Management as it relates to data governance and GMP records
- Informed of and support to site investigations, as needed, related to Data Integrity.
- 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.
- May participate in external DI forum.
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: quality operations, 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: quality operations, compliance, manufacturing operations, technical operations, or IT.
Required Experience, Skills, and Knowledge:
- Strong Understanding and knowledge of Data Integrity Expectations and experience delivering strategic data integrity projects.
- Working knowledge of computerized systems / IT required, including SDLC.
- Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes.
- Demonstrated Leadership Skills
- Excellent written and oral communication and presentation 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
- Is a self-starter, takes initiative to solve difficult problems in creative ways
- 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 develop and execute on organizational change management, communication, engagement strategies
- Ability to be decisive and influence management with demonstrated leadership skills
- Experience in managing cross-functional initiatives or programs
- Broad organizational and business acumen, demonstrated ability to link finances to business outcomes and benefits
- 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 and/or Manufacturing operations 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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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:
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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.
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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, 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob 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:R299737
