职位描述
职位描述：
PRINCIPAL RESPONSIBILITIES:
Responsible for providing expert strategy, direction, and advice to BRQC and business partners related to global GxP regulatory requirements.
Responsible for leading and contributing to the strategic design and implementation of an effective and proactive inspection readiness and management framework to optimally prepare and support inspections.
Responsible for leading the coordination of inspection preparation, conduct and post-inspection activities (at least for major inspections).
Responsible for providing strategic direction for communication with Regulatory Authorities post inspections, including the Regulatory Compliance review and input to inspection observation responses prior to the submission and the oversight of inspection commitments ensuring documented evidence of completion.
Responsible for providing independent and expert strategic direction and advice for Regulatory Authority communications (non inspectionresponse related).
Responsible for ongoing monitoring (mining) of external industry and internal J&J inspection outcomes and trends, ensuring this information is proactively shared within BRQC and Business partners and effectively used to shape the Regulatory Compliance mock inspection program
Responsible for executing a GXP mock inspection program that proactively identifies areas of inspection risks and tests R&D’s level of inspection readiness.
Responsible for performing routine periodic audits of BRQC functions providing assurance that internal BRQC processes are compliant with internal and external requirements.
Responsible for leading the conduct or coordination of special investigations.
Responsible for supporting BRQC/Business Partners through significant compliance remediation activities, providing expert regulatory compliance advice and solutions.
Responsible for external influencing, working with the regulators, defining key strategies for influencing with regional Health Authorities.
Responsible for contributing to an effective quality and compliance regulatory Intelligence operation by monitoring global/regional/local regulatory requirements and supporting internal impact assessments for new/changing requirements
In collaboration with other members of BRQC ensures key business partners and corporate compliance partners are advised of critical compliance issues that relate to Regulatory Authority and ERC activity.
Provides strategic leadership, coaching, and mentoring to BRQC colleagues.
Qualifications
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
Requires at least 10 years of experience with 3 plus years experience and demonstrated leadership in a quality function working on complex and significant compliance topics. Must have comprehensive knowledge of worldwide GCP, GLP, PV, and IT compliance regulations and guidelines. Requires knowledge of latest auditing, investigation and remediation techniques as well as leadership experience with inspections.
Demonstrated effective influencing, interpersonal, written and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations. Regulatory Authority experience is desirable.
BS required. Masters in related field, advanced degree desirable.
RELATED EXPERIENCE:
Experience with Regulatory Authorities is a significant asset.
Experience working with device, diagnostic and cosmetic product classifications (in addition to pharmaceuticals) is desirable.
Experience with associated compliance systems such as GMP, GTP, and HCC.
