Senior Associate, Quality Management Systems (Product Complaints)

Location
South San Francisco, California
Posted
May 10, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Description  

The Senior Associate, Quality Management Systems (QMS), will be responsible for the design, improvement, execution and implementation of the GMP Product Complaints electronic system (Product Complaints Process) at Portola. In addition to establishing and improving the Product Complaint process, the successful candidate will support the implementation and on-going improvement of other QMS processes, including but not limited to, metrics for all processes that support the Management Review (MR), Annual Product Quality Review (APQR), and Supplier Management. The Senior Associate will address gaps associated with the current processes as part of preparing for future clinical and commercial operations.

 Responsibilities:

  • Execute the Product Complaints system
  • Initiate, investigate, and close clinical and commercial Product Complaints
  • Ensure the internal Product Complaints System effectively integrates with the Adverse Events process and is compliant with current regulatory expectations
  • Establish, track, and report quality metrics for Product Complaints and present improvement opportunities at Management Review meetings
  • Implement and improve risk management based approaches to Product Complaints.
  • Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes
  • Facilitate and improve Portola’s Supplier Management program
  • Manage the Approved Supplier List (ASL)
  • Ensure suppliers have executed Quality Agreements

 Qualifications:

  • BA/BS degree in scientific or engineering discipline
  • Six (6) to eight (8) plus-years of biopharmaceutical industry experience
  • Prior management of clinical and commercial Product Complaints processes plus direct experience working with training processes In-depth understanding of current global regulatory expectations
  • Demonstrated ability to collaborate and influence across the organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
  • Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders and management
  • Ability to meet deadlines and multi-task efficiently
  • Comfortable in a fast-paced environment with minimal direction and changing priorities
  • Experience identifying changes, driving improvements and streamlining processes
  • Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project
  • Experience in preparing for and participating in regulatory inspections to ensure successful outcomes preferred
  • Direct experience with managing other key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review, Product Complaints) a plus