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: + 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 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/page review, executed batch record review, and product disposition. 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: 2-10 Essential Functions + Primary Quality Management contact. Primary Quality Management contact for key customers + Primary Quality Management contact for all on-the-floor processing-stopping incidents + Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports + Manages the oversight, review and approval of deviation investigations and change controls pertaining to CGMP production and testing + Supports the establishment, preparation, and communication of quality metrics. Identifies and works with function areas as appropriate to facilitate improvements + Interacts and communicates with customers to assure expectations are established, agreed to, and achieved + Engages actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintains effective and professional communication between all parties, including the customer + Understands the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances + 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 + Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development + Develops and maintains labor model using the forecasted production schedule; uses the labor model to maintain adequate coverage for all shifts + Responsible for release of all products; may delegate as needed + Reviews and approves deviations, CAPAs, Effectiveness Checks, and Chang Controls as needed + Maintains safe and healthy work environment by establishing and enforcing organization standards, adhering to legal regulations + Represent Quality Assurance Program in Customer Joint Steering Committees + All other duties assigned (QMS) + Primary Quality Management contact for the change control process and requirements across the site. Lead and facilitate change control review boards as applicable + Take responsibility of the risk management process and the risk register across the Bloomington site + Manage the document management process and system across the site + Supports the establishment, preparation, and communication of QMR quality metrics for the Bloomington site and identifies and works with function areas as appropriate to facilitate improvements + Understands the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances + Manages QA resources assigned to supporting CGMP programs + 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 + Interacts and communicates with customers to assure expectations are established, agreed to, and achieved + Engages actively with other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintains effective and professional communication between all parties, including the customer + Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development + All other duties 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. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Qualifications + Education/Experience: + Bachelor’s degree + Master’s degree preferred + 10 years GMP experience or other regulated industry + 5 years providing quality assurance support to cGMP pharmaceutical production or other regulated industry + 5-8 years of leadership experience + Must be able to read and understand English-written job instructions and safety requirements + Technical Requirements: + 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 + Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process + Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones + Well organized with ability to handle and direct multiple activities within site or across sites simultaneously + Supports site quality improvement initiatives + Develops a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement + Functions as a strong Quality liaison to other functional department, providing meaningful quality support and ensuring productive cross-functional communication + Drives systemic process changes as a result of Deviations/Complaints and other quality trends + Behavioral Requirements: + Makes informed quality decisions without oversight + Shares own ideas in a compelling manner that gains commitment from organization + Inspires and persuades others to pursue and achieve goals + Negotiates skilfully and professionally and persuades others to approach complex organizational issues in the same manner + Wins concessions while building relationships or knowing when to yield to another's point of view. Teaches peers the art of persuasion + Anticipates reactions and positions of others and plans accordingly and mentors peers to do the same + Takes a proactive approach to shape and influence internal and external executive stakeholder expectations across the organization + Serves as a liaison between different sites and BU for strategic programs and cross function alignment + Effectively aligns and influences the interests of multiple executive stakeholders (client programs and company) with different priorities to quickly drive decisions to complex conflicts with broad organizational impact + Ability to see and hear, read, and write clear English + Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing + Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner + Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time + Ability to cooperate with coworkers within an organized team environment or work alone + Detail oriented with ability to work effectively under high pressure with multiple deadlines + Strong ability to multi-task in a fast pace environment + Positive attitude and ability to work with others + Ability to process a large volume of work + Ability to effectively carry out and implement change + Ability to put aside personal opinions and focus on business needs, department needs, or group needs + Leadership Requirements: + Applies technical, functional, business and/or industry knowledge to design experiments or project scopes; provide scientific or business consultation to the site and executive leadership team and manage multiple functions and/or focuses across site disciplines + Actively defines and executes on the strategic direction of the department by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information + Manages strategic activities across departments and global sites. Defines and leads multisite strategic initiatives + Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan + Makes implementation plans and assignments that allocate strategic and inter-site resources appropriately to complete objective and drive development opportunities + Prepares strategies to deal with anticipated problems or drastic changes for department and company initiatives and team's projects + Identifies activities with relevant milestones and schedules to effectively manage the progress and performance of team and own work developing metrics to monitor performance to goal and establishing best practices with multiple site impact + 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 + Establishes an effective, professional, and positive relationship with employees + Clarifies responsibilities and expectations and holds employees accountable + Participates in and conducts timely HR-related processes + Provides timely constructive feedback that is clear and direct + Provides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performance + Uses appropriate methods and flexible interpersonal style and coaching to develop others’ capabilities + Recognizes and reinforces developmental efforts, progress, and improvements + Collaboratively works with direct reports to set meaningful performance objectives 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.