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Engaged Employer

Tracelink

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3.1

based on 47 Reviews

19 Tracelink Jobs

Director, Regulatory & Quality Compliance

TraceLink Inc.

3.1

based on 47 Reviews

10-11 years

Pune

1 vacancy

Director, Regulatory & Quality Compliance

Tracelink

posted 11d ago

Job Role Insights

Flexible timing

Key skills for the job

Supply Chain Management Customer Support Legal Advisory Auditing Life Sciences Information Security

+ 3 more

Job Description

In this role, you will act as a people manager within the RQC team, leading staff and providing strategy to ensure compliance with the TraceLink quality management system, relevant global regulations (e.g., ISO 9001, Part 11), and corporate policies regarding Software Development, IT, Customer Support and Service delivery for TraceLink s SaaS applications and related products. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Report noncompliance issues and/or identified risks to TraceLink senior management and, where applicable, TraceLink information security.

Responsibilities

Provide strategy for growing and maintaining TraceLink s Quality Management System
Collaborate with Head of RQC to provide strategy for the RQC department, budget planning, and team development
Hire, manage, and develop personnel to meet demand and within budgeted guidelines
Maintain existing quality certifications (ISO 9001) and identify opportunities for additional certifications
Maintain, modify, and grow the corporate Quality Management System to comply with applicable industry standards and federal regulations (e.g., ISO 9001, 21 CFR Part 11, Annex 11, GxP, data integrity), to support continual improvements, and per corporate strategic goals
Manage revision and approval of the Quality Management System (QMS) documents, including but not limited to periodic SOP reviews, change control, document management system (eQMS), control of records, electronic signatures, and good documentation practices
Monitor compliance to the Quality Management System and QMS-related global regulations for the company s policies & procedures related to Software Development, Professional Services, Support, and IT organizations
Lead/Perform internal quality audits of the organization, including authoring plans and reports, tracking findings and follow up
Perform vendor qualifications per corporate policies and procedures regarding vendor oversight and reporting
Oversee QMS employee training program, compliance monitoring, eLMS system, and continual improvement efforts
Support Security department audits and certifications (ISO 27001, SOC2)
Support the Corrective and Preventative Action (CAPA) program for tickets related to the above areas
Support hosting of customer audits and provide responses to customer audit reports for the above areas
Stay abreast of applicable industry standard and federal regulations, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality, with a primary focus on software in the life sciences industry
Provide input and guidance from a regulatory and quality perspective across functional areas to facilitate decision-making
Provide support towards the improvement of quality system, training, and records management programs across the organization and all functions

Skills and Qualifications

Essential

10 + years of progressive quality experience
BE BTech/BS, MS Computer Sciences required
Audit or Quality Certifications: ISO Certified Lead Auditor, Quality Management
Strong knowledge of the pharmaceutical industry and SaaS technology
Previous experience as a manager in pharmaceutical or technology quality assurance or compliance areas
Highly developed and proven project management skills with an acute attention to details
Highly developed and proven written and verbal communication skills

Desirable

Master s Degree preferred but not required
Experience with global teams across time zones and geographies
In addition to pharmaceutical industry expertise: prefer experience with Medical Device, HIPAA, and/or Data Privacy
Familiarity with US FDA 21 CFR 820/211, ICH Q9, Q10

Employment Type: Full Time, Permanent

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