Director – Quality Assurance Job
Novo Nordisk US Bio Production, Inc. has an exciting opportunity for a detail oriented, quality minded, individual to lead the Quality culture as Director – Quality Assurance. The Director – Quality Assurance is responsible for leading quality initiatives and culture for NNUSBPI management team ensuring that it meets the Novo Nordisk Quality Policy, QMS, and Quality objectives for the site and company. The person in this role will direct and coordinate the activities of the Quality Assurance team to support the production of Biopharm products through quality assurance programs which meet or exceed business, regulatory, and customer requirements in accordance with the Novo Nordisk Way. This role is responsible for Formulating, communicating and implementing corporate strategy that effectively supports the manufacture of Biopharm products through quality assurance programs that ensure safe, effective, and pure products.
Key Accountable Areas:
- This position is responsible for leading the strategic and tactical activities for Quality Assurance, Quality Systems, and Quality Compliance, at NNUSBPI.
- Responsible to manage areas above via subordinate management by setting direction, following up to ensure progress and goal attainment, and to provide feedback and coaching. A high level of innovation and collaboration is expected to continuously improve QMS processes and achieve improved quality at NNUSBPI.
Main job tasks:
- Execute Novo Nordisk Quality System at Site NH to ensure that products are designed, manufactured and shipped to customers such that quality, safety, and effectiveness are assured.
- Execute procedures and criteria for the release of product and distribution of production, .
- Formulate, communicate and implement corporate and local strategies that effectively supports the manufacturing of Biopharm products through quality assurance programs to ensure safe, effective and pure products.
- Maintain an accurate and up-to-date knowledge of international and national standards and guidelines in Site NH’s area of activity.
- Responsible to lead, develop, and recruit a highly effective staff of appropriate technical depth to support current needs and future growth Site NH.
- Ensure that current rules and regulations are complied with within NNUSBPI and the marketing authorization is kept. Responsible for quality assurance of all aspects of production of API products at NNUSBPI: Control and status assignment of API products
- QA responsible for process validations of products produced for market
- Control and approval of all GMP documents and documentation in the department
- Participation in building and re-building projects in the departments
- Provide GMP education and communicate Quality Mindset
- Principal respondent to Health Authority audits at NNUSBPI
- Plan and ensure professional execution of inspections
- As member of the management team in NNUSBPI and Quality Biopharm:
- Ensure a high level of quality in NNUSBPI
- Always communicate Quality Mindset
- Support NNUSBPI management team in follow up on quality KPIs, QMR, inspections, etc.
- Ensure compliance in own department
- Direct and manage quality management team which includes but is not limited to the following:
- Set objectives for the department
- Assure that the department meets goals and KPI’s in the area
- Strategic planning for the department
- Organizational planning and objective setting
- Policy development
- Assure that the department builds up and maintains working procedures and systems to assure
- cGMP compliance and good housekeeping
- High quality of work in all ways
- Effective and flexible case handling
- Recruitment/selection
- Personnel training and development
- General management according to NNWay
- Assure development of employees
- Assure that employees in the department are trained and motivated according to NNs visions and goals
- Maintaining a healthy and engaging working environment in the department
- Assure manning and back-up for key personnel
- Define and follow-up budget for the department
- Assure implementation and comply with cLEAN (including continuous process improvements via cLEAN methodologies)
- Assure that all relevant HR activities are executed
- Set objectives for the department
- As member of NNUSBPI management team, responsible to participate in setting goals, objectives, policy and continuous improvement projects.
- Personnel and budget responsibilities for NNUSBPI QA
- Assure planning and optimal use of resources in the department.
- Follow all safety and environmental requirements in the performance of duties.
- Perform other duties as assigned.
- Assures all activities comply with established company policies and perform all duties in compliance with global regulatory requirements, the NNUSBPI Quality Manual and SOPs.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.
Other individual assignments:
- Establishes and chairs the CAPA forum for NNUSBPI
Knowledge, skills & abilities and experience:
Education:
- Bachelor’s Degree in science, engineering, MS/MSC is preferred.
Experience:
- Minimum 10 years’ experience in pharmaceutical quality, manufacturing or a related area.
- Minimum 5 years’ supervisory/management experience in pharmaceutical industry.
- A minimum of five (5) years’ experience in a licensed drug, device, or biologic facility regulated by FDA, EMEA or a leading international agency in a quality role.
Skills & abilities:
- Exceptional communication skills and the proven ability to integrate into a team and manage complex projects.
- Strong computer skills.
- Strong presentation skills.
- Strong planning and organizational skills, and flexibility to change work priorities as necessary.
- Must have practical experience in working with the U.S. and international requirements for biologicals and/or pharmaceuticals.
Requisition ID: 56800BR
State/Provinces: West Lebanon
Job Category: Quality
Requirements:
CAPA, Compliance, Engineer, Engineering, Facilities, Healthcare, Housekeeping, Law, Legal, Management, Manager, Operations, Pharmaceutical, QA, Quality, Quality Assurance, Quality Manager, Science, Strategic Planning, Strategy, Technology
