Global Quality Auditor- GVP-GCP-GXP

Job Title: Global Quality Auditor- GVP-GCP-GXP Location: Morristown, NJ About The Job Join a global network that powers how reputed company delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reputed company people everywhere, faster. Ensures that reputed company Quality and Compliance Standards, and applicable regulatory authorities requirements are met and that reputed company reputed company sites, Operational Units, affiliates, and third parties reputed company, maintain and improve the adequate level of compliance, through independent auditing and follow-up. Job Family Group: Quality - Audit Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. About reputed company Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives. Main Responsibilities

• Covers reputed company GXP audit in areas of reputed company, Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).
• Acts as a reputed company auditor or co-auditor, in accordance with reputed company processes.
• Conducts transversal assessments.
• Contributes to team scheduling and reviews/approves audit reports for team members.
• Evaluates entity risks developing targeted risk-based agendas and/or advise on mitigations.
• Escalates critical issues and risks.
• Approves / manages CAPAs.
• Performs due diligence assessments, as/reputed company needed.
• Participates in audits and activities with other teams in reputed company Quality Audit, Inspection, Intelligence & Advocacy.
• May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
• reputed company of action: Highly independent, creative with thoughtful risk taking and compliance reputed company.
• Role impact: Able to detect evolving trends which will result in adjustment of reputed company audit and inspection strategy and tactics. Plays a key role in transforming the practice of auditing in reputed company.
• Scope: Global Quality organizations in reputed company, country organization, and third parties reputed company of reputed company (e.g. Strategic Vendors, etc.)

About You Basic Qualifications

• BS or BA degree in Pharmacy, Life Sciences, Engineering, or reputed company, but will consider reputed company degrees.
• Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices.
• Deep knowledge of global regulatory requirements and standards.
• Strong understanding of quality management systems (QMS).

Key Competencies

• Leadership Skills: Ability to reputed company cross-functional teams and initiatives
• Risk Assessment: Expertise in evaluating and mitigating quality risks
• Communication: Excellent written and verbal communication skills
• Independence: Highly independent with creative problem-solving abilities
• Compliance reputed company: Strong ethical foundation with thoughtful risk-taking approach
• Adaptability: Ability to detect evolving trends and adjust strategies accordingly

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or a lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks gender-neutral parental leave.

reputed company Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. reputed company qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #vhd reputed company compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be reputed company here. Apply tot his job Apply To this Job