Director - Validation and Compliance

Confidential
  • Boston
  • Confidential
  • 10-15 years
  • 131 Views
  • 27 Mar 2015
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  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Primary Function:

The Director of Validation and Compliance Services leads the CSOD Validation and Compliance offering and supporting team. The Director of Validation and Compliance Services designs and leads our service offerings and points of view on all regulatory compliance areas. This role manages a small team across the US and EMEA, is the expert to our clients, prospects and partners with the technology team on all audit and compliance activities. The Director of Validation and Compliance Services will be responsible for providing leadership support in the sales cycle, oversee development of statements of work with regard to service delivery In addition, the Director will work closely with the Technology teams and other teams across the company to improve validation processes, implement a Quality Management System with the goal of providing independent oversight of organizational processes as they related to validated systems.

Responsibilities:

Accomplishes compliance and regulatory business objectives by producing value-added employee results; offering information and opinion as a member of senior management; integrating objectives with sales, product, technology, development, delivery and support; directing employees.

Establishes compliance operational strategies by evaluating trends; establishing critical measurements; determining production, productivity, quality, and customer-service strategies; designing systems; accumulating resources; resolving problems; implementing change
Develops compliance financial strategies by estimating, forecasting, and anticipating requirements, trends, and variances; aligning monetary resources; developing action plans; measuring and analyzing results; initiating corrective actions; minimizing the impact of variances across CSOD compliance business
Protects CSOD assets by establishing CSOD compliance standards; anticipating emerging 21 CFR part 11 compliance trends; designing improvements to internal control structure
Avoids legal challenges by understanding current and proposed 21 CFR part 11 legislation; enforcing regulations; recommending new procedures; complying with legal requirements
Attracts new clients by maintaining CSOD compliance programs; bringing compliance recognition to the company; providing leadership in the industry
Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations
Enhances compliance and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
Works with other CSOD teams to improve audit readiness, documentation and evidence
Acts as primary liaison for pharma industry audits and any necessary follow-up
Oversees the implementation and management of CSOD's Quality Management System

Key areas of responsibility include:

Pre-Sales Support
Oversight of Compliance Scoping of Engagements
Corporate Compliance Needs
Product Enhancements
Validation Maintenance
Service Delivery
Validation Tasks
Audit Remediation Tasks

Experience/Qualifications:

Bachelors' degree in Engineering or the Physical or Biological Sciences. 10-15 years quality, compliance and regulatory experience in the medical device or other regulated manufacturing environment 5 years managing an audit program and conducting audits in the medical device or drug industry preferably in a corporate function
Demonstrated leadership ability and experience. Demonstrated ability to self-motivate Working knowledge/experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals and combination products. Applied understanding of QSR (21 CFR Part 820), Medical Device Reporting (21 CFR Part 806), Enforcement Policy (21 CFR Part 7), ISO 13485, European Medical Device Directive, and Canadian Medical Device Regulations (CMDR)
Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
Demonstrated ability to work effectively with a variety of work groups, including cross functional teams, to assure conformance to regulatory requirements, internal processes and procedures
Provides proactive guidance/advice and solutions regarding questions on compliance related issues to the organization