Senior Manager, Document Control (FFEx)

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 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

Manage a team of Associate Managers, documentation area specialists & technical writers, as well as related processes. Oversee and control GMP and construction/engineering documentation for all work packages. Collaborate with Global Process Responsible, as well as local document authors & owners, in the implementation/improvement of documentation standards. Coordinate technical writing, related Change Request (CR) management & communication support while working closely with key stakeholders, including but not limited to Records Management Control (RMC) & Corporate Document Control Unit (DCU).

Relationships

Director.

Essential Functions

• Coordinate with global process responsible to ensure development & release of framework standards
• Support the successful translation of vendor and global standards into site standards
• Ensure proper workload distribution among team members
• Lead a team of Associate Managers and a Sr Process Specialist, as well as managing daily activities of the documentation area specialists & records management associates, to include but not limited to staff selection, process confirmation, expectation setting & employee development
• Ensure site technical writing processes for Standard Operating Procedures (SOPs), including QBIQ documentation system & non-QBIQ documents, are followed to standard
• Coordinate & collaborate with global teams to establish & develop documentation standards & practices
• Plan & execute improvements for documentation processes based on input & feedback from documentation customers
• Coordinate activities associated with updating SOPs with all internal stakeholders
• Ensure compliance requirements are being followed, and inspection readiness is in place
• Effectively organize & manage multi-disciplined project team to ensure all critical deliverables are met
• Act as a champion & role model for the NNWay & for cLEAN® (process improvement) thinking & behaviors
• Follow all safety, financial & environmental requirements in 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 business or technical field from an accredited university required
• Master’s degree in a business management field preferred
• Minimum of eight (8) years of experience in a manufacturing organization required, preferably in a pharmaceutical manufacturing environment
• Minimum of seven (7) years of direct supervisory experience required
• Knowledgeable in Novo Nordisk (NN) processes, GMP, NN QMS & standards improvement systems preferred
• cLEAN® 2-Star or equivalent process improvement methodologies knowledge such as LEAN, Six Sigma, etc. & a proven track record in leading measurable process/performance improvements required
• Ability to read, write & improve complicated product documentation & standard operating procedures with attention to high-level concepts required
• Expert in change control (CR), MS WORD 2010 & highly proficient in the following software applications/tools: Adobe Acrobat Pro (latest version), EXCEL, PowerPoint, Visio & HTML required
• Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams preferred
• Ability to relate well to a wide cross section of stakeholders required
• Demonstrated strong skills in change management required, preferably within NN

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.