PurposeThe Specialist, Quality Audits and Relationship Management, is responsible for maintaining, establishing and improving Novo Nordisk Inc.’s (NNI) end-to-end Quality audit program. In the role of Quality Lead Auditor, the position is responsible for all aspects of Quality auditing, including Quality audit planning, execution, reporting and follow-up to ensure compliance with all applicable GxP regulations, and Novo Nordisk policies and procedures. The GxP regulations that apply include GMP (Manufacturing), GDP (Distribution) and GPV (Pharmacovigilance) regulations.
This position is also responsible for conducting Quality review of NNI contracts and implementing Quality Agreements with vendors, as appropriate. This position is also responsible for driving continuous improvement projects within the department and affiliate.RelationshipsExternal relationships include interactions with NNI vendors during auditing functions and routine networking.
Interfaces with NNI clients and NN A/S Global Quality and Product Safety departments, as needed.
Maintains positive rapport and working relationships within and across departments in relation to assigned tasks. Collaborates on high level activities defined by quality process optimization projects.
Reports to a member of the Quality Leadership Team within NNI Quality Assurance.Essential FunctionsPrimary Functions
Conducts internal/external ISO/GxP audits, including audit planning, audit conduct, audit reporting and audit follow-up, as assigned.
In the role of Audit Coordinator, conducts the quality audit risk assessment for NNI in order to establish audit frequency, establishes the audit plan, updates the audit plan and monitors audit progress and status.
Follows up on supplier audit responses and corrective action plans to ensure effective and timely problem resolution; Promotes a culture of structured problem solving with suppliers.
Will own and report on all quality issues associated with suppliers to the Quality Leadership Team and to Corporate Quality, as appropriate.
Audits, inspection and contract review; responsible for the routine follow-up and closure of corrective and/or preventative actions (CAPAs) stemming from internal inspections and/or external vendor audits.
Provides Quality support to corporate internal audits within NNI.
Develops and maintains an annual Quality audit schedule for NNI. Routinely updates the schedule to include new suppliers, as appropriate.
Develops, maintains and routinely updates the GxP Approved Supplier Listing in conjunction with NNI Contract Owners.
Performs Quality review of vendor contracts to ensure the implementation of the appropriate quality language. Implements Quality Agreements (QAAs) with external vendors, where applicable.
Participates in and/or leads cross-functional teams, as needed. Collaborates with and/or leads cross-functional departments to execute approved projects aimed at increasing overall quality of business within their responsible area(s).
Actively seeks out industry best practice and implements them within NNI, where appropriate.
Establishes, maintains and communicates metrics (KPIs) to ensure all objectives are met.
Ensures that all local activities within areas of responsibility are in compliance with local and federal regulations, global and local SOPs, and other governing standards.
Authors and/or provides Quality support to other Quality system processes as assigned by management, including, for example, Non-conformances (NCs), Corrective and Preventive Actions (CAPAs), Change Controls, SOPs and /or training.Essential Functions ContinuedPhysical Requirements20-30% overnight travel required
May require international travel.Development of PeopleNot ApplicableQualificationA Bachelor’s degree required; advanced degree preferred.
A minimum of 6 years of experience relating to pharmaceutical industry within Quality, Regulatory, Product Safety or other similar role in a global environment, demonstrating a steady career progression with increasing responsibility is required.
Required in-depth knowledge of GxP (GMP/GDP/GPV) regulations, standards, policies and procedures.
Ability to read and understand technical and non-technical documents as related to contracts, procedures, policies and specifications.
Ability to read, write, speak and understand English fluently and at a professional level.
Strong speaker/presentation skills in the role of Lead Auditor.
ISO 9001 Lead Auditor, Certified Quality Auditor (CQA) or Global Exemplar Lead Auditor training and/or certification is strongly preferred.
Ability to proactively anticipate multiple deadlines, and drive and manage project priorities is required. Excellent interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment.
Strong project management and organizational skills.
Working knowledge of Quality Systems processes, including Non-conformances, Corrective and Prevention Actions (CAPAs), Change Controls, SOPs and/or training.
Department CMR - PRODUCT SAFETY
Position Location US - Plainsboro, NJ
State/Provinces US - NJ
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.