Senior Project Manager, Validation-Site Capacity

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Senior Project Manager, Validation-Site Capacity

Clayton, NC, US

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance – reimbursement up to $10,000 annually
• 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.

Position Purpose

Overall responsible to lead the validation project team & activities in the IFP Expansion program. Serves as point of entry in coordination & execution of validation. Ensures relevant compliance issues are addressed & handled in close collaboration with Quality & project tracks.

Accountabilities

• Builds, manages, & strategically directs the validation team, comprised of internal employees (managers & technical individual contributors) & external contractors, to include staff selection, coaching/developing, performance management for internal employees & setting department objectives & expectations
• Guides & makes technical decisions for the validation strategy & cGMP/regulatory compliance
• Partners with the global expansion team to ensure Science & Risk Based Validation (SRV) program alignment
• Sets performance management targets & oversees follow-up
• Prioritizes tasks, ensures timeline adherence, & delivers progression report out based on schedule
• Develops & oversees process improvements of standards for Validation processes
• Provides & supports a professional, engaging, cooperative, & high achieving work environment for employees
• Contributes to the site Quality Management team through strategy development & risk management
• Ensures robust processes are in place to exceed quality objectives & requirement
• Champions PSPS & Continuous Improvement processes in the team
• Promotes positive collaboration with internal & external stakeholders
• Participates in regulatory inspections & internal audits
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Required Qualifications

• Bachelor’s degree in engineering or related field of study from an accredited university required. With P&O review/agreement, equivalent combination of education & internal NN business/operational experience may be substituted for degree as appropriate
• Minimum of eight (8) years of experience in a manufacturing organization required, pharmaceutical manufacturing preferred
• Minimum of seven (7) years of direct supervisory experience required
• Minimum of five (5) years of experience planning maintenance &/or calibration activities required
• Minimum of five (5) years of experience investigating GMP calibration or instrument failures required
• Minimum of five (5) years of experience in preparing technical instructions/procedures required
• Advanced knowledge of US, EU regulations & guidelines, & application of GMP’s required
• Demonstrated expertise in validation activities & dependencies spanning equipment, process, cleaning, & computer systems required
• Working knowledge of cGMPs, corporate & site level requirements & procedures required
• Demonstrated ability to write technical documents, instructions & reports required
• Demonstrated ability to present technical information to others required
• Working knowledge of Word & Excel software applications required
• Working knowledge of handling & accounting for measurement uncertainty required
• Demonstrated ability to manage multiple tasks & responsibilities with competing priorities required
• Demonstrated systematic approach to problem solving & troubleshooting required

Physical & Other Requirements

• Ability to work in an open office environment with the possibility of frequent distraction
• Constantly operates a computer & other office equipment
• Ability to adjust schedule to work with colleagues in other international time zones
• Ability to travel internationally, as requested (up to 20%)