SENIOR QUALITY AND COMPLIANCE SPECIALIST

Under the management of the Quality and Regulatory Compliance Lead, the Sr.
Quality and Regulatory Compliance specialist acts as the Change Control / Document Control and Nonconformance / CAPA process owner for the GATT site.
This position drives the continuous education, implementation and improvement of Quality Systems and compliance with QS regulation and ISO within the GATT facility and ensures that the site's Document & Change Control / Nonconformance / CAPA Processes and structure meet all business and regulatory requirements.
Furthermore, this position acts as the backup of the Quality and Regulatory Compliance Lead and provides guidance and assistance to ensure process procedures are compliant with applicable regulations and standards, such as, good laboratory practices, good clinical practices, quality system regulations, and organization of international standards including administrative support to the Quality organization as necessary.
DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Ensures quality systems are effectively deployed and performs periodic checks to verify appropriate application.
Uses complex statistical methods, quality tools and computer-generated reports to continuously improve process capability Maintains regular interface with Management and assists in the development of Quality Metrics to achieve company's Quality goals.
Acts as the Change and Document Control process owner at the site and ensures adherence of the process at the site as well as acts as SME for this process during regulatory inspections Represents the site on the worldwide NC and CAPA teams.
Acts as the Nonconformance and CAPA process owner at the site and ensures adherence of the process at the site as well as acts as SME for this process during regulatory inspections Provides education/training as needed regarding Document and Change Control, NC and CAPA.
Presents data analysis to the DRB and Management Review, as appropriate.
Reports NC and CAPA scorecard results, as needed.
Leads and participates in quality system improvement initiatives.
Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.
Determines root causes of quality issues and develops corrective actions and recommendations.
Suggests process changes when appropriate.
Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely manner.
Responsible for the Site Records Management being the Site Record Management representative.
Backup on other tasks within QS department to assure business continuity, if required.
Responsible for communicating business related issues or opportunities to next management level Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Qualifications University / bachelor’s Degree or Equivalent Requires a minimum of 4-6 years work experience.
Medical device manufacturing experience preferred.
Able to communicate and writing skills in English.
Mathematical and analytical thinking skills Minimum of 3 years in similar environment with medical device or pharmaceutical.
Thorough understanding of medically regulated plant operations including knowledge of industry standards & regulations, processes and practices in a variety of different departments and operations preferred.
Experience in dealing with audits preferred (Notified bodies and/or Competent Authorities).
Flexibility, integrity, independency and serve minded Ability to work independently and in teams Ability to communicate effectively, orally and in writing, with employees of various disciplines and departments.
Ability to accurately perform detail-oriented work.
Ability to maintain accuracy, consistency and quality of documentation and projects.
Ability to function in a controlled manner regulated by FDA cGMPs & ISO standards, and handle confidential data.
Ability to effectively and efficiently develop and/or enhance quality system processes while ensuring compliance to applicable regulatory standards.
Strong communication, human relation, problem solving and analytical skills.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to write and communicate in English and preferably in Dutch.
Ability to read, analyze, and interpret general business periodicals, professional journals and government regulations.
Ability to write reports, business correspondence and standard operating procedures.