Warehouse Quality Assurance & Reg Professional - Virginia

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

This role is responsible for overseeing and ensuring adherence to quality and regulatory standards within the warehouse facility. In addition, the role will provide quality related support for warehouse logistics, operations, and sampling. This role will serve as the quality coordinator for all warehouse operations.

Relationships

Reports to Manager.

Essential Functions

• Responsible for maintaining and supporting daily operations related to quality compliance
• Promote and foster collaborative efforts across departments to ensure compliance with relevant regulations and standards
• Author and revise standard operating procedures, job instructions, training outlines, rationales, risk assessments and department GMP documents
• Author and support quality related deviations, change requests, & risk assessments
• Author & support Deviations and CAPAs
• Develop and maintain all warehouse quality documents and ensure proper archival process
• Develop and deliver warehouse quality and GMP training to employees
• Ensure NNWAY guidelines are followed in daily operations and in collaboration with departments and relevant stakeholders to ensure robust processes and compliance
• Oversee Quality Management Review (QMR) Warehouse, Raw Materials, & Sampling QC
• Drive audit preparation & prepare presentations in support of audits & inspections
• Ensure sampling processes are in alignment with Quality Control
• Ensure structured processes and procedures are in place for optimal operations
• Serve as the main warehouse support on daily operational challenges
• Lead, mentor, and coach employee’s quality matters
• Drive implementation of cLEAN® (LEAN/Six Sigma) principles with a focus on warehouse operations
• Follow all safety and environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Qualifications

• Bachelor's Degree in pharmaceutical science, quality management, business, logistics, engineering or related field from an accredited university required
• May consider an Associate’s degree from an accredited college with eleven (11) years of experience in warehouse and quality operations
• Minimum of seven (7) years of experience in warehouse and quality operations required
• Minimum of three (3) years of experience operating in a GMP-regulated environment a plus
• Experience with building up quality systems a plus
• Knowledge about requirements & expectations from authorities, e.g. FDA required
• Proven ability to establish & maintain networks & to facilitate processes that encourage cross organizational knowledge sharing preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.