Director Quality Assurance

A pharmaceutical company in Massachusetts is currently seeking an experienced professional to join their growing team as their new Associate Director, Quality Assurance Operations. In this role, the Associate Director, Quality Assurance Operations will be responsible for the Quality oversite for a manufacturing area (such as Drug Substance) as well as provide "on the floor" oversite of downstream purification manufacturing activities.

The information below covers the role requirements, expected candidate experience, and accompanying qualifications.

This is an onsite contract role in Bedford, MA

Responsibilities :

Provide on the floor quality operations support for all areas and own the master batch record lifecycle processes including final review and approval

Provide technical quality guidance as part of teams conducting investigations for complex manufacturing events

Review and approve complex deviations and / or Investigations that are site specific

Actively support and / or lead preparation activities for pre-approval Inspections and / or responses to observations

Work with product release teams to support issuance of drug substance Certificates of Conformance and any other disposition required activities.

Manage CAPA records and may be required to function as a CAPA manager for minor or major CAPA as needed

Serve as QA Reviewer or impact assessor for downstream purification change control records

Support and / or review various reports from quality systems and ensure quality mindset is strong

Own various Quality procedures and ensure the systems / processes are deployed effectively

Qualifications :

8+ years of leadership / management experience in an Operations, Manufacturing Technology or Technical Quality professional role

Bachelor's Degree

Excellent technical and regulatory understanding of the downstream drug substance purification processes

Strong experience with various root cause analysis techniques such as 5-why, Kepner-Tregoe, force-field analysis, DMAIC, fault tree analysis

Strong understanding of industry regulations such as CFR, USP, EP, JP, etc.

Demonstrates strong quality judgement in various situation when making decision

Desired Skills :

Master's Degree in Biological and / or Chemical Sciences