Skip to main content

This job has expired

You will need to login before you can apply for a job.

Director, Operational Standards - FFEx

Employer
Novo Nordisk
Location
Clayton, NC
Start date
Aug 27, 2024

Job Details

About the Department                                                                                                                                               

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

 

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

 

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

• 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

Provides leadership & guidance to people leaders & SME's responsible for operational readiness by building & leading the operational standards team. The operational standards lead will be the single point of contact to ensure operational standards are created, deployed, and maintained at the local project/manufacturing site. This will include all operational standard areas: Training, ramp-up, procedures, process definition, supply chain, organization strategy, digital use cases, and maintenance. The team leader will contribute to a positive, constructive & ambitious work environment in department leadership teams as well as in own area of responsibility.

 

Relationships

Project Vice President.

 

Essential Functions

  • Manage operational aspects of the Project to include cost, quality & schedule requirements in area of responsibility
  • Develop, coach & lead department leadership & Subject Matter Experts (SMEs) to ensure a high performing collaborative team environment
  • Lead Global Workstreams that will provide the framework for future facility standard operations globally
  • Provide Global leadership and input to set the global future maintenance strategy by capturing current best practice and methodology from operating sites and industry best practices
  • Lead the Global Operational Standard workstream and local SMEs to map, define, and document critical aseptic processes
  • Lead the local site in development and coordination globally of operational standard tracks (including: Ramp-Up, Training, Operational Standards, Supply Chain, Training, and Organization Strategy)
  • Develop the strategy with the expansion management team & line of business to ensure successful project execution
  • Act as the primary conduit between the expansion program and the current operating site to ensure alignment
  • Collaborate with project department leadership & provide oversight for development, coaching, performance management, recruitment & employee relations
  • Ensure robust processes are set in place to ensure all quality objectives, specifications, and requirements can be monitored and achieved in the operating facility
  • Drive project performance to ensure all processes necessary to support aseptic and finished production are identified and tracked to completion (Voice of Operations)
  • Lead strategic activities to drive operational performance & process/technical improvements ensuring standardization across shift teams
  • Set direction by developing transparent process objectives based on site goals
  • Act as the single point of contact representing the local operational standards area globally
  • Drive operational standardization & collaboration across the local project team and with other expansion sites
  • Provide strategic resource planning to operating the process in a cLEAN® way
  • Follow all safety & 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.)

     

    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 directly related field from an accredited university required
  • Minimum ten (10) years in lean production manufacturing required
  • Minimum seven (7) years of proven leadership experience in Manufacturing, Engineering &/or Production required
  • Experience leading technical SMEs preferred
  • Minimum five (5) years of managing other managers experience required
  • Experience with both Aseptic Production and Finished Production required
  • Project Management competencies obtained through relevant PM training or experience required
  • Knowledgeable in core work processes & GMP concepts preferred
  • Experience with performing process FMECAs required
  • Experience with training for competency preferred
  • Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
  • Demonstrates functional/business understanding as well as superior written & oral communication skills required
  • Extensive knowledge of project management including the ability to create work plans & detailed project schedules preferred
  • Proficient in problem solving, negotiation, conflict management & interpersonal skills required
  • Ability to act as project lead & lead cross functional project teams in the development & implementation of projects required
  • Ability to influence others on objectives & projects outcomes required
  • Basic understanding of contractual documents required
  • Ability to read/review design drawings (CAD) with a basic understanding of P&ID’s required
  • Thorough understanding of technical documents such as URS, SAT, FAT & Validation Protocols required
  • Proven expertise in mentoring & development of people leaders, change management, planning & organizing, managing execution, & revising work plans for complex issues addressed by cross-functional teams 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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

    CONNECT

    FacebookTwitter YouTube Logo Instagram

    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

    Get job alerts

    Create a job alert and receive personalized job recommendations straight to your inbox.

    Create alert