Under the guidance of the head of the External Quality Assurance (EQA) Compliance Team, the EQA Change Control Lead will be responsible for setting the strategy for the Change Analyst role and will be the primary SME for the Change Control Quality System within the external network. This position will be responsible for leading efforts to implement Integrated Product Information, a global system aimed to transform how to we execute end to end change control. This role will support External Quality Assurance including Drug Products, API, Strategic Alliances, Corporate Alliances. The EQA Change Control Lead will be the interface with Technical Operations and other change owners and will be required to keep up to date with the latest regulatory expectations and divisional expectations for change control.
Responsibilities include but are not limited to:
?Lead the preparation and execution of strategic and continuous improvement efforts related to change control
?Primary Change Control Quality System Owner for EQA
?Coordinate and facilitate Quality Manual Gap Assessments associated with change control
?Lead efforts for implementation of IPI
?Continue to progress the change analyst role
?Manage a small team of change analysts
Position can be based at any of our company's US locations.
Education Minimum Requirement:
? Minimum Bachelors Degree in life science, science, engineering, or related areas of study.
Required Experience and Skills:
?Minimum 7 years applied professional work in the pharmaceutical industry
?Strong aptitude for understanding regulatory systems and processes
?Strong interpersonal, influence, and negotiation skills across all levels
?Effective at energizing others, establishing clear goals, mentoring and coaching team members
?Demonstrated situational leadership and creative problem solving within teams
?Ability to understand details, but keep the overall \"big picture\" view of projects and strategies
Preferred Experience and Skills:
?Experience with change control and associated material control
?Experience in project management methodologies
If you need an accommodation for the application process please email us at ...@merck.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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