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Quality and Compliance Specialist - 2406182246W
Description
Under the management of the Quality and Regulatory Compliance Lead, the Quality and Regulatory Compliance specialist acts as the Internal Audit process owner and support function for the External Audit Management process at 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 Internal Audit 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:
External inspection readiness and associated activities. Lead and manage site audit readiness activities to ensure inspection readiness at all time, including:
Back Room leading function during inspections/ audits (BSI, etc).
Audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.).
Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
Provide timely information to support the inspection process, including those that maybe taking place at other sites / locations.
Ensure adequate corrective actions for external audit observations related to site.
Internal Audit Program and Management Execution
Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
Participate in internal / external audits and perform Internal Audits.
Metrics Collection and Reporting
Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
Drive compliance to Quality and Compliance metric targets.
Create reports and communicate performance against metrics to key stakeholders.
Highlight/communicate adverse trends in metrics and take risk-based action to remediate.
Site Management Review
Provide input into Site Management Reviews (e.g., internal audits.) to allow meaningful review.
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 3-5 years work experience. Medical device manufacturing experience preferred.
Able to communicate and writing skills in English
Mathematical and analytical thinking skills
Internal Auditor Qualification and experience in conducting internal audits for at least 2 years
Minimum of 2 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.
Ability to read, analyze, and interpret general business periodicals, professional journals and government regulations.
Ability to write reports, business correspondence and standard operating procedures.
Primary Location Europe/Middle East/Africa-Netherlands-Gelderland-Nijmegen
Organization 8354-GATT Technologies B.V. Legal Entity
Job Function Quality Systems
Req ID: 2406182246W