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Associate Director, Project Manager/Database Administration Job - United States  

Company managed [?] Still accepting applications

Posted on : 16 April 2017

Project Description

Associate Director, Project Manager/Database Administration-BUS002110

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Position Overview – Basic Functions & Responsibility Essential function(s) includes, but is not limited to:

- Design/Develop plans to successfully implement department dashboard, metrics, trends, and reports 60% of time.

- Leads and/or supports data entry and new projects and status reporting.

- Collaborates and supports the Executive Director/Delegate analyzing CAPA performance, setting up, analyzing trending, and maintaining effectiveness checks monthly. This will include inputs of team members.

- Lead/Co-lead administration of teamspace and community page for design and alignment of global QA knowledge sharing including calendar, discussion board, and templates.

- Provides support as an SME in various areas of regulatory requirements and supports team with CAPA database including data entry.

Primary Activities Primary activities include, but are not limited to:

- Design, Develop program/project plans, calendar schedules, tracking updates, maintenance, and ensure timelines for CAPA program and/or projects meeting established expectations. This requires approximately 25% worldwide travel.

- Design, develop, analyze, and report CAPA trends, metrics, including effectiveness checks.

- Maintain a broad based expertise of cGMP's, Merck Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.

- Serve as “Subject Matter Expert” for project management and process owner for CAPA stakeholders; generate and deliver cutting-edge training for a diverse audience

- Maintain awareness of evolving industry and regulatory trends/regulations. Lead/support CAPA trending/site risk profiles, metric and report generation as input to Sr. Management Quality Council

- Provides support and administrative functions for the electronic CAPA and Reporting Systems and assists in data entry and maintenance.

- Develops/presents training to team in relevant tools for project management, schedule, analysis and reporting, as needed.

- Supports on adhoc basis CAPA review, inspection readiness, inspection support, and/or remediation for computer/automation systems and/or data integrity across the network.

Skills (include specific skill levels required to apply Merck Leadership Principles)

- Minimum of 10 years of project management in a manufacturing, technology, and/or quality assurance including experience within an FDA and/or EU pharmaceutical, API, Drug Product, or Medical Device environment.

- Program/project planning within Quality/compliance experience in an FDA and/or EU regulated industry.

- Experience with development of metric dashboards, schedules, analyzing statistical and report trends, including development of effectiveness checks supporting Corrective Action and Preventative Actions (CAPA).

- Thorough understanding of Quality Management Systems for API’s, drugs products, and medical devices, including risk management. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

- Ability to travel globally approximately 25% of the time.

- Ability to work independently with limited supervision in a virtual-management environment

- Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, or Sterile Drug Product manufacture including project management and database administration role.

- Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization.

Qualifications

Education Minimum Requirement:

- Bachelor's degree or equivalent degree.

Required Experience and Skills:

- Minimum of 10 years of professional experience in manufacturing, technology, and/or quality assurance.
- Project Management experience in a FDA/EU pharmaceutical, API, Drug Product, or Medical Device environment.

- Experience with development of metric dashboards, schedules, analyzing statistical and report trends.

- Strong understanding of Quality Management Systems.
- Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

- Ability to travel globally approximately 25% of the time.

- Ability to work independently with limited supervision in a virtual-management environment

- Experience with database administration.

Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels

Preferred Experience and Skills:

- Strong experience in project management, database administration, and SharePoint or TrackWise experience.
- Development of effectiveness checks supporting Corrective Action and Preventative Actions (CAPA).

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Business Consulting

Job Title:Assoc. Dir, Business Consulting

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck


Nearest Major Market: Philadelphia

Job Segment: System Administrator, Database, Manager, Project Manager, Medical, Technology, Management, Healthcare