Sr. Director, QA RA, Americas

Ansell Located in: Iselin,  New Jersey
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JOB DESCRIPTION

JOB  DESCRIPTION

Sr. Director, QARA, Americas

Position located in Iselin NJ

GENERAL SUMMARY OF POSITION:

  • Oversee Americas region Quality Assurance and Regulatory Affairs by directing and coordinating activities consistent with established company and management goals, objectives, Medical Devices, PPEs, ISO guidelines and policies.
  • Promote the development and implementation of a region-wide culture of quality excellence and  understanding of the key elements related to quality system and regulatory compliance requirements, in accordance with Corporate objectives
  • Oversee the strategic direction, preparation and progress of regulatory agency and notified body submissions
  • Organize and lead the knowledge construction of existing and emerging regulations, standards, or guidance documents. Interpret regulatory rules or rule changes and ensure that they are communicated throughout corporate policies and procedures
  • Serve as a management representative for regulatory agency, notified body and customer audits.
  • Act as the senior QARA point person for the Regional Management team on the Regulatory requirements for medical devices and PPEs, and provides guidance and action plans on desired best-in class QA practices for the Americas Region.
  • Work in close relationship with the EMEA-APAC QARA Senior Director to achieve harmonized QA processes and where applicable and relevant, common and shared regulatory strategies

RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES

  • Responsible for driving quality excellence throughout the Americas organization by providing overall strategic direction and guidance for the quality system and regulatory activities.
  • Responsible for overall management of existing and future Quality and Regulatory practices, procedures and teams to achieve desired outcomes (registrations, new offices ISO and/or local certification, QMS rationalization) with optimal quality, efficiency and cost-effective approach
  • Define a well-balanced lobbying approach within relevant MD and/or PPE organizations, including but not limited to EC MedTech, KOSHA (examples only) with objective to promote data-driven education and awareness within the international regulatory bodies.  
  • Ultimate decision maker to ensure that all company products meet applicable quality & regulatory standards in the market of sale.
  • Ensure that clinical evidence to support product registration and marketing claims relating to individual products is of the required standard
  • Participate as a member of Americas Executive Leadership team.
  • Develop strategies, KPI’s and written business policies aligned with organizational goals and regulations

CRITICAL REQUIREMENTS

  • KEY POSITION REQUIREMENTS

    Education


              
    • Bachelor’s Degree in Engineering, Science, Technology or related field

    •         
    • Master’s Degree a plus

    Job Experience


              
    • 10-15 years of QA and RA management experience in medical device and PPE manufacturing industry with 5 years in senior leadership position.

    •         
    • Audit Management

    •         
    • Business Transformation Programs support

    •         
    • People management responsibility (10 FTEs or more)

    •         
    • Experience in dealing with complex product issues and working across multiple functions and locations (matrix organization) to meet requirements and

    Knowledge and Skills

    Extensive knowledge in


              
    • ISO 13485 & ISO 9001 Audits, Vigilance Reporting, CE Markings

    •         
    • Product Registration, including Medical Devices and PPE,  FDA 510 K, REACH Regulation, Risk management ISO 14971, 21 CFR 820.20 (optional),

    •         
    • Due Diligence, CAPA Management, Lean Six Sigma, Quality Auditing, 21 CFR Part 11, Quality Management, Technical Documentation, Design Control, GMP.

    •         
    • Quality Management Systems (implementation, harmonization of all QMS on European level)

    •         
    • CAPAs

    •         
    • Advanced computer proficiently with MS Office and solid experience working with ERP and eQMS software (eg; Trackwise)

    •         
    • Quality Audit training.

    •         
    • Fluent English is a necessity

COMPANY INFORMATION

Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives. We are innovators striving to create advanced solutions and technology that will solve the challenges industrial workers, countries work to create a safer and protected world. Our vision is to create a world where people can enjoy optimal protection against the risk they are exposed to. Whether at work or outside the workplace, people require the right protection for the right application. After all, what better guarantee is there than increased safety, security and productivity than through adequate protection.

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  Regulatory Affairs,  Quality
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
Education Required:
Any