BioTalent | Quality Assurance Manager

3 days ago

santa barbara county, United States BioTalent Full time

*Seeking experience with Medical Device as well as familiarity with GMP drug product release to work on-site


The site quality leader is responsible for ensuring that core functions of Quality Assurance are consistently in compliance with regulatory requirements. This involves assuring quality standards (FDA, ISO, CMDCAS, Medical Device Directive (MDD), Medical Device Regulation (MDR) and Canadian Medical Device requirements) with respect to such processes as Inspection, Document Controls, CAPA, Nonconforming Materials, Complaints and Internal Auditing. This position is granted the authority to take any actions required to fulfill the scope, duties and responsibilities of this position, including Management Representative.


KEY RESPONSIBILITIES:

  • Develop, establish and maintain QA processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulations.
  • Oversee the documentation process for Device History Records; propose, draft, review and approve new or revised SOPs, job instructions and related forms relative to the quality assurance program or other programs which may impact the quality assurance program.
  • Provide guidance to Operations personnel in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
  • Direct and supervise daily activities of QA/QC staff involved in receiving, in-process and final inspection, complaint investigation, Corrective and Preventive Action (CAPA) process and document control to ensure compliance to quality standards/regulations.
  • Responsible for Risk Management, communicating risk policies and processes for the organization. Ensures risk management procedures are fully effective and followed throughout appropriate business tasks involving the Quality Management System.
  • Responsible for hiring and training quality assurance personnel as required supporting the above processes.
  • Generate ideas and leads efforts at the facility to identify root causes of quality issues and implement processes to resolve and prevent issues.
  • Lead the Corrective and Preventive Action process and participate in Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities.
  • Facilitate the Change Control Board (CCB) meetings to review and disposition Change Orders (CO).
  • Lead ISO internal audit, train and develop internal auditors and issue audit reports.
  • Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits.
  • Evaluate employees through performance reviews, ongoing coaching and feedback methods.Analyze and resolve or assist employees in solving work issue. Maintain discipline, morale and team relationship within the QA/QC group.
  • Provide quality data, trending/statistical reports to the RA/QA Director.
  • Participates in special projects and performs other duties as required.
  • Serve as the Management Representative and ensure that quality management system is established, implemented and maintained in a manner consistent with applicable quality system standards and regulations. Report the performance of the quality management system to top management and where improvements are needed.


PREFERRED BACKGROUND:

  • Bachelor's Degree required, Master's degree preferred
  • 8-10+ years of increasing responsibility in Quality related roles within the Medical Device and Life Sciences industries
  • 1+ years of management experience
  • Strong management and leadership skills and ability to attract, retain, motivate, develop and mentor team members for high performance.
  • Outstanding verbal and written communication skills and ability to resolve disputes effectively.
  • Excellent presentation and public speaking skills.
  • Excellent independent decision making, analysis and problem solving skills.
  • Understand and act on financial information that contributes to business profitability.
  • Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility.
  • Lead team(s) to achieve company goals in creative and effective ways.
  • Excellent planning and organizational skills and techniques.
  • Communicate effectively with senior management.
  • Good negotiating skills and ability to effectively manage outsourced relationships.
  • Ability to influence, build relationships, understand organizational complexities and manage conflict.
  • Broad professional and managerial skills with a good understanding of industry practices and company policies and procedures.
  • Ability to lead virtual teams

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