Associate Director overseeing Quality Assurance group for pharmaceutical manufacturing. Implementing cGMP practices and managing compliance for Devens and North Andover sites.
About the role
- QA Specialist ensuring compliance in pharmaceutical manufacturing at Novo Nordisk. Responsible for training QA team and driving quality improvement projects in a GMP facility.
Responsibilities
- Responsible for training, mentoring and developing other QA colleagues
- Responsible for identifying and assessing training needs and delivering training materials and programs
- Serve as Good Manufacturing Practice (GMP) expert that responsible for evaluating and improving the effectiveness of training programs
- Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues
- Inform stakeholders regarding project goals and deliverables
- Consult and mentor across business operations and provide specialized knowledge
- Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting/trending
- Reviews and approves Validation Documentation
- Reviews and assesses Corrective and Preventive Action Reports
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
- Other duties as assigned
Requirements
- Bachelor’s Degree within a scientific or life science required
- Master’s Degree preferred
- Bachelor’s Degree with ten (10) years experience required
- Master’s Degree with eight (8) years experience preferred
- Six (6) years of direct QA experience preferred
- Excellent written and verbal communication and negotiating skills in English are required
- Strong planning and organization skills, with flexibility for changes in work priorities
- Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
- Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors
- Ability to train and/or mentor Junior team members in QA Best Practices
- Extensive knowledge in GMP API manufacturing in the pharmaceutical Industry
- Have proven experience with GMP manufacturing in the pharmaceutical industry
- Have good stakeholder management skills and collaboration skills at all levels of the organization.
Benefits
- Inclusive recruitment process
- Equality of opportunity for all job applicants
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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