Job title: Senior Project Manager – Validation – United States Sourcing Hub
Company: Novo Nordisk
Job description: About the Department
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, 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 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 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.
The Position
Responsible for leading the validation and qualification of large-scale commercial projects for facility, utility, equipment, and system & cleaning activities. Serves as the Subject Matter Expert (SME) for industry standards and validation compliance requirements and supply support/technical knowledge for the development/refinement and implementation of validation standards. Work with site leadership to manage and create group strategy and systems, allocate resources to projects, and manage timelines for qualification projects. Will lead and provide daily direction to internal and external support for validation projects.
Relationships
Reports to the Project Director.
Essential Functions
- Serve as Lead for all large-scale validation projects while sourcing external support for commissioning and validation activities
- Develop scope of work for investment projects to include submitting and reviewing bids from externals, providing analysis, and recommendations for vendor selection
- Initiate, design, and evaluate plans for site projects, to include the planning and execution of all tasks needed to meet goals
- Execute priorities and consider long range project planning through consultation with supervisor while demonstrating good project and employee management skills
- Maintain up-to-date schedules, budgets, & risk assessments for projects as well as knowledge of validation standards and regulatory compliance requirements
- Serve as the SME for equipment qualification, laboratory equipment qualification, facility/utility qualification, control system qualification, and associated systems and procedures
- Contribute to long-term strategic development of validation program, including mentoring activities for the development of the Validation team, policies & procedures development and the development of the Validation Team & validation practices to ensure compliance
- Analyze and interpret validation data, make independent tactical decisions based on data and develop project strategies with consultation with supervisor
- Lead the preparation and execution of validation protocols, data analysis, and final reporting
- Provide validation input and direct support during regulatory inspections
- Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
- Implement department action plans based on the results from internal or external audits, CAPA (Corrective and Preventive Actions), and exception management processes
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Physical Requirements
May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
Development of People
Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
- Bachelor’s degree in a relevant field of study from an accredited university required
- Master’s degree in a relevant field of study from an accredited university preferred
- PMP (Project Management Professional) certification preferred
- Minimum of fifteen (15) years of experience in the pharmaceutical or biotechnology industry required
- Minimum of seven (7) years of direct supervisory experience required
- Minimum of ten (10) years of experience in proven validation experience required
- Proven background of leading medium and large-scale projects from design, through installation, commissioning, and qualification, and into commercial use required
- Strong project management skills, developing and tracking budgets and schedules for projects, and providing inputs into project risk analysis required
- Strong understanding of: Validation concepts, international cGMP regulations and other industry standards pertaining to validation, and the technical requirements for Validation and of biopharmaceutical equipment, facilities, and/or instrumentation required
- Strong work ethic (self-motivated) honesty, excellent communication skills, and the ability to work in teams-displays initiative and commitment required
- Proven experience supervising teams required
- Excellent communication skills and ability to work in teams required
- Proven validation management within an FDA and EMEA regulated production facility required
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.
Expected salary: $10000 per year
Location: Clayton, NC
Job date: Wed, 25 Oct 2023 22:50:28 GMT
