Description:
This position is based primarily at our Rowley Manufacturing Facility and includes occasional travel to the Ipswich and Beverly locations.
Primary Responsibilities:
- Develop, support and execute Site Validation Programs, Validation Master Plan(s) and work with third party validation contract resources, as needed, to deliver project goals.
- Host and/or participate in external customer and third-party audits, including Notified Bodies, to clearly and convincingly present Quality and Validation systems, data, reports, procedures and records as requested.
- Populate Quality System questionnaires to communicate NEB Quality System
- Conduct Internal Audits to assess compliance of other departments to seek continuous improvements.
- Work directly with customers to identify mutually agreed solutions and respond to Quality related inquiries.
- Work independently and within a team to identify and implement solutions to complex issues ensuring compliance and product needs are met.
- Issue, review and reconcile NEB and CMO Production and/or testing records.
- Ensure CMO Quality Systems are maintained to meet NEB requirements.
- Lead Batch Release responsibilities for Intermediate and Final Products.
- Conduct investigations of customer complaints, product non-conformances and deviations as needed.
- Review of work orders to assess impact and need for change controls and/or deviations.
- Monitor and present metrics, KPI’s and system status summaries to Senior Management on a routine basis.
- Design and execute periodic Quality or Validation Systems training(s) for NEB staff.
- This position may also provide support for global projects and Contract Manufactures for outsourced production of NEB products.
- In addition to the above responsibilities, ensure the successful management and timely execution of Quality Systems, including: CAPA, OOS Investigations, Supplier Corrective Actions, Risk Assessments, Material Management, Supplier Management, Technical Transfer.
Required Qualifications and Experience:
- B.S. / B.A. degree in Engineering, Biology, Molecular Biology, Microbiology or related life science field; advance degree preferred.
- Minimum 8 years’ experience in biotech, pharmaceutical or medical device industries, with at least 4 years’ direct experience in a professional quality role(s). Previous experience in a GxP organization is required
- Demonstrated knowledge and hands-on experience executing Quality and Validation Systems while working within an ISO 13485, ISO 9001 and/or cGMP structured environment.
- Demonstrated knowledge in system optimization projects via use of Operational Excellence concepts and techniques such as DMAIC, PDCA, SPC, FMEA, Kaizen, Lean Manufacturing, 5 Whys, Key Performance Indicators, Visual Management...etc.
- Strong project management skills and ability to oversee third party contract resources.
- Strong interpersonal skills with the ability to collaborate closely with NEB staff of all levels to drive Quality System improvements while delivering necessary compliance requirements.
- Keen attention to detail
- Possess strong written and verbal communication skills.
- Ability to evaluate multiple inputs and provide recommendations on resolution.
- The ability to travel periodically up to 5-10% is required.