Staff Quality Systems Specialist I – Lead Auditor

Staff Quality Systems Specialist I – Lead Auditor

Requirements

• Demonstrated ability to lead, motivate and accomplish results through experienced direct reports and peers.
• Ability to organize and prioritize assignments providing direction to assigned functional teams.
• Demonstrates effective written and verbal communication skills across all levels.
• Ability to speak with clarity and manage conflict resolution in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
• Ability and skill to effectively manage multiple tasks and lead execution of change management plans.
• Ability and skill to lead or manage the Quality System function for complex systems, continuous improvement projects and project management techniques.
• Ability to act as a liaison across functions and with outside customer representatives or stakeholders concerning operational or project schedules/deliverables, audits, etc.
• Thorough knowledge and understanding of the food and Drug Administration (FDA) 21 CFR 820 and International organization for Standardization (ISO) and other worldwide regulations.
• BS Degree in Life Science, Engineering or equivalent program.
• A minimum of 7-10 years experience in Quality Management/Quality Systems/ Audit Program Management.
• FDA and other MDR/IVDR Regulatory inspection experience.

Responsibilities

• Collects, interprets and analyzes data and presents to others either orally or in writing.
• Independently designs quality plans consistent with project objectives.
• Acts independently, consults with supervisor on unusual situations.
• May train, develop or assign work to others; provides technical and or supervisory guidance to others.
• Responsible to maintain budget as assigned and assure balance of resource allocation, dollars and equipment.
• Is the prime technical contact on projects and interacts with senior external personnel.
• Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies.
• Develops, documents and executes Baltimore wide Quality Audit Program.
• Coordinates with other DS sites to assure that each site has fully compliant Quality System Audit Program.
• Develops and implements DS wide audit report ‘Peer Review’ program so that audit reporting across the business is uniform, current and effective.
• Supports DS wide Quality System Audit Program by providing independent auditing service when there is a need for support in any particular site.
• Initiates a DS wide Audit Data Trending Programs for management input.
• Supports DS wide continual improvement effort by continually raising the compliance bar during Quality System Audits.
• Assures appropriate corrective action program is implemented for nonconformance issued during internal audits.
• Represents BDDS on cross-business teams related to Quality System Audits.
• Functions on corporate initiated teams regarding implementation and best practice strategies for highly visible Quality System Audit programs.
• Identifies best practices between BD divisions and Corporate to develop one common system.
• Develops and provides compliance/ audit training, including training for auditors and auditees.
• Partners with other quality professionals to address recurring issues identified throughout the organization.
• Provides and analyzes organizational quality audit metrics as required to generate quality system improvements.

Preferred Qualifications

• RABQSA or equivalent certification is highly preferred.
• Other Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc).