Quality Assurance Manager


Job ID 18-00017

Industry Pharma

Job Type Permanent

Location Bridgewater, NJ

Description

Position summary:
This position is responsible for the Quality Management System and Quality Team, ensuring compliance with FDA regulations, ISO 13485 and other applicable standards/regulations.
Essential responsibilities:
As the designated FDA and ISO 13485 Management Representative and Quality Department Subject Matter Expert, responsibilities include:

  • Establish, implement and maintain Quality Management Systems to meet FDA 21CFR820, ISO13485, and other regulatory requirements as applicable. Systems include (but not limited to): Change Management; Document and Record Control; NCR; CAPA; Complaints; Validation; Stability; Audits; Training.
  • Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies. Identify and investigate potential trends for improvement initiatives.
  • Support the implementation and maintenance of an innovative Global Quality Management System (QMS) and associated infrastructure that is compliant, effective, efficient and agile. Support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth.
  • Manage, mentor and develop QA and QC team (4 personnel) to support operational demands and business objectives. Specifically including; incoming, in-process and finished goods testing and batch release processes for all products dispatched. Establish and maintain effective cross-functional relationships for a collaborative and cohesive corporate culture.
  • Prepare, monitor and execute quality plans and metrics reports to support attainment of business objectives and regulatory compliance (including budgets, Management Reviews and audits executed to planned schedules and closure of corrective actions as required by regulations). Oversee the execution and timely closure of all open items.
  • Oversee and manage facility inspections and audits required by government / regulatory agencies and related agency communication. Drive and leverage agency collaboration for risk management and continuous improvement.
  • Act as Quality SME and provide training/consultation to internal and external customers on applicable regulatory requirements (proactively and reactively) and Quality Systems in general.
  • Perform medical device reporting and vigilance activities when required.
  • Ensure continuous improvement of the Quality Management System and other department processes as appropriate
  • Provide strong managerial, leadership and business office skills. Promote cross-functional and inter-business collaboration across US-sites and between business subsidiaries internationally. Provide forward-thinking strategic guidance for projects and workflows to drive consistency, efficiency and simplicity. Manage projects independently with a minimum of managerial oversight.
  • Be fully fluent in written and spoken English, including being able to craft business communications in a manner that is free of grammatical and/or typographical errors and that clearly conveys the intent of writer / speaker.
  • Oversee ownership, maintenance and compliance of Design History and Technical Files, Validation activities, Risk Management files, Supplier files and program (including supplier qualifications, performance monitoring and audits). Ensure maintenance of product design and labeling in accordance with registrations/clearances/approvals as appropriate.
  • Review and approve policies, procedures, and instructions as required by the business. Provide training to support implementation of the Quality Management System.
  • Maintain current professional and best practice knowledge. Completes required continuous training and education, including department specific requirements. Conduct must reflect the Company's values and a commitment to the Code of Conduct ethics and compliance program.
  • Other duties as assigned


Qualifications

Qualifications:

  • Authorization to work in the United States indefinitely without restriction or sponsorship

Education/Experience:

  • Bachelor's degree in Engineering, Science, Healthcare or the equivalent knowledge and experience is required/preferred
  • 5-7 years in medical devices or IVD industry work experience. Including in a high-volume FDA-registered manufacturing environment, with responsibility for review/approval of Engineering Change Orders and awareness of Design Controls/Product development (equivalent experience will be considered).
  • 2y experience managing direct reports
  • Auditing experience in GMP environments to FDA and ISO standards (ISO lead auditor certification preferred). Experience managing external agency audits by regulatory and/or notified bodies.
  • RAC certification preferred, ASQ - CQA, CQE or SCQE
  • Lean/six sigma experience preferred
  • Working knowledge with 21CFR820, ISO13485, ISO14971, IVDD required (CLIA and US state DOH regulations for laboratories preferred)
  • Basic lab experience – pipetting, GLP, hazard awareness

Skills/knowledge/cultural fit:

  • Highly detail oriented with effective time management, scheduling, and organizational skills. Able to organise and track complex information and efficiency focused.
  • Able to effect Quality Improvement through stakeholder management, influencing skills, problem solving and knowledge of quality tools such as FMEA, root cause analysis, lean manufacturing etc. Interpret regulatory requirements, communicate context to the team internally and translate to practise
  • Possess excellent written and verbal communication skills in a professional and team-oriented manner. Including Strong technical-writing - able to read, write, review and approve protocols, reports, investigations, business correspondences, and procedures for clarity, organisation, structure and simplicity. Ability to effectively present information and respond to questions from management, staff and the general public. Able to read, analyze, and interpret technical data, reports, professional journals, and governmental regulations and standards.
  • Enjoys training, collaboration, team work, managing and developing people to their fullest potential. Demonstrates conflict-resolution skills and escalates risk appropriately with discretion.
  • Independent and autonomous, ability to plan, prioritise, manage projects and tasks to timelines.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate high quality documentation, follow instructions, and comply with company policies
  • Strong collaboration, problem solving and analytical skills, must be analytical, flexible, innovative, and self-motivated
  • Demonstrates high ethical standards in business practices. Actively supports organizational goals and changes as they occur. Communicates goals in positive, supportive manner.
  • Conduct must reflect the Company's values and a commitment to the Code of Conduct ethics and compliance program.
  • Must have the flexibility to work extra hours to meet departmental goals and availability to shift hours enabling work across timezones when required. Must be available for international travel to collaborate and support fellow subsidiaries if required.
  • Understand requirements for occupational health and safety and basic awareness of Good Laboratory Practice (preferred)
  • Passion for contributing to a growing and successful international business
  • Thrive on opportunity to excel and contribute