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Director of Product Quality and Communications (PQC) at BD
San Diego, California, USA -
Full Time

Start Date

Immediate

Expiry Date

16 Oct, 25

Salary

322500.0

Posted On

17 Jul, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Process Excellence, Business Units, Quality Operations, Continuous Improvement, Communications, Regulatory Affairs, Commitments, Quality System, Design Assurance, Escalation, Adverse Events, Sas, Leadership, International Standards, Remediation, Complex Systems

Industry

Pharmaceuticals

Description
Responsibilities
  • Facilitates the collection of information and technical writing of communications with FDA and other regulatory agencies, including periodic reports for responses to audits and inspections, enhanced post-market surveillance reports, field remediation reports, “Additional Information Requests” related to inquiries about adverse events, device malfunctions, or recalls, and other communications
  • Facilitates the implementation of commitments made to FDA and other regulatory agencies, including end-to-end process improvements, procedural updates, design/manufacturing/labeling changes, etc.
  • Coordinates and facilitates a unified approach and process for CAPA initiation determination processes leading to the creation of CAPAs, product investigations (SAs) and escalation to Field Action decision, as applicable.
  • Collaborates with leadership in Business Unit Quality, Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional Compliance, and Post Market Quality on the review and approval of the communications
  • Actively participates in inspections and audits at the San Diego, Tijuana, and other sites as required, including pre-inspection activities, inspection management, responses, and remediation
  • Actively participates in workshops for process or product improvements at the San Diego, Tijuana, and other sites as required
  • Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business unit projects and reports to meet established goal