Staff Quality Systems Specialist I - Lead Auditor

Job Description Summary

Staff Quality Systems Specialist I - Lead Auditor is responsible for providing Quality and/or technical leadership/supervision to product/projects/systems and direct report teams. Directly accountable for multiple projects within department or has accountability for programs across multiple plants.

Conceptualizes, prioritizes and schedules project deliverables. Determines feasibility of project features, deliverables and resource availability to recommend viable options. Leads continuous improvement activities for the DS Quality System.

The Staff Quality Systems Specialist I - Lead Auditor is directly responsible to the WW Quality Systems Director for the DS-wide development, improvement and implementation of Quality Systems programs. The Staff Quality Systems Specialist I - Lead Auditor is accountable for assuring that all DS sites comply with ISO and FDA (or primary regulations of their respective countries) through the implementation of effective internal quality system audit program and ensuing effective corrective actions/ preventive actions.

• Collects, interprets and analyzes data and presents to others either orally or in writing. Understands and leverages published Quality System and regulatory agency requirements and leverages best practices. Makes recommendations for project direction including alternative solutions.
• Independently designs quality plans consistent with project objectives. Readily applies Quality System principles to the solution of complex technical problems.
• Acts independently, consults with supervisor on unusual situations.
• May train, develop or assign work to others; provides technical and or supervisory guidance to others. May be responsible for on contribute to the assessment and development of associates who are dotted line reports. May have direct reports.
• 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.

• 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.
• RABQSA or equivalent certification is highly preferred. Other Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc)
• A minimum of 7-10 years experience in Quality Management/Quality Systems/ Audit Program Management.
• FDA and other MDR/IVDR Regulatory inspection experience.