Director, QA

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.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.  

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. 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 Quality Assurance department is responsible for all aspects of the quality assurance functions. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities.

Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.

The Position

Relationships

Reports to: Director or Above

Direct Reports: 5 – 12

Work Location: Required to be onsite

Essential Functions

• Is accountable for the performance and results of multiple related teams
• Develops departmental plans, including business, production and/or organizational priorities up to 6-18+ months in advance
• Decisions are guided by policies, procedures, resource availability and functional objectives
• Provides leadership and direction through managers
• Provides technical guidance to employees, colleagues and/or customers
• Collaborates and communicates with support functions
• Reviews and approves GMP documentations while ensuring safety and GMP quality compliance
• Supports and leads continuous improvement projects
• Creates the strategic direction of quality and customer-oriented process to maximize customer satisfaction, while optimizing cost effectiveness
• Hires, trains, motivates, leads, develops, and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate
• Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results
• Designs and implements new or improved systems and processes to drive improvement in levels of customer satisfaction
• Manages and leads key initiatives for the site’s working capital management
• Is responsible for driving performance to target in the key indicators for operations-oriented measures
• Creates and supports, the implementation and execution of best practice processes such as Lean, Six Sigma, CAPA, ERP/JDE, SIOP
• Maintains effectiveness of the Quality System components relevant to this position
• Provides key input and reports that support financial revenue budget and reporting
• Responsible for the data integrity, management and communication of all operations related plans and schedules at the facility
• Drives compliance with all applicable corporate and regulatory SOP and cGMP guidelines for their area of responsibility
• Leads team members to improve and reinforce performance of others
• Takes responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
• Works with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
• Other duties as assigned

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled.

Qualifications

• Education/Experience:
  • Bachelor’s degree
  • Master’s degree preferred
  • 12 years GMP experience or other regulated industry
  • 7 years providing quality assurance support to cGMP pharmaceutical production or other regulated industry
  • 6-9 years of leadership experience
• Technical Requirements:
  • Ability to see and hear, read, and write clear English
  • Excellent written and verbal communication skills with internal and external customers
  • Ability to communicate complex technical information to non-technical audiences
  • Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
  • Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
  • Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process
  • Experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones
  • Well organized with ability to handle and direct multiple activities across departments simultaneously
  • Ability to use Excel, Word, and other office systems, as well as programs for multiple pieces of manufacturing equipment
  • Ability to peer review data to ensure data is well organized with complete documentation
  • Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions
  • Ability to problem solve to initiate and execute/monitor corrective action
  • Ability to write SOPs, batch production records and reports independently
  • Ability to work with and lead other groups to develop, qualify and transfer methods, and drive complete investigation, deviation, and change control practices
  • Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify and transfer methods accordingly
  • Strong interpersonal and presentation skills to discuss technical concepts internally and with clients
  • Ability to learn and use software packages (e.g., TrackWise®, pcMRP, ComplianceWire®)
  • Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.)
  • Can effectively back-up Senior Director to address technical or business issues
  • Provides reliable/defendable interpretations of regulatory guidance for the customer and can defend these positions to regulatory agencies

• Behavioral Requirements:
  • Shares own ideas in a compelling manner that gains commitment from others
  • Inspires and persuades others to voluntarily follow direction
  • Negotiates skillfully and professionally and persuades others to approach issues in the same manner
  • Anticipates reactions and positions of others and plans accordingly. Mentors team to do the same
  • Takes a proactive approach to shape and influence internal and external executive stakeholder expectations
  • Serves as a liaison between different stakeholder groups across departments
  • Effectively aligns and influences the interests of multiple stakeholders (client programs and company) with different priorities to quickly drive complex decisions
• Leadership Requirements (if applicable):
  • Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus
  • Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline
  • Manages strategic or continuous improvement activities with the team, across teams within the department, or across multiple departments within the site. Coordinates with teams in other departments and across the business unit
  • Helps identify department objectives to align with site goals. Regularly communicates to team, department, and company about department priorities and how aligned
  • Makes implementation plans and assignments that allocate cross functional resources appropriately to complete objective and provide development opportunities
  • Anticipates challenges and opportunities and adjusts contingency plans for department initiatives and team's project
  • Identifies initiatives with relevant milestones and schedules to effectively manage the progress and performance of the team and own work developing metrics to monitor performance to goal

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.