Associate Director, Quality Assurance Operations

Innova Solutions•Bedford, MA

7d•Onsite

About The Position

Innova Solutions is seeking an Associate Director, Quality Assurance Operations for a full-time, contract position lasting 3+ months in Bedford, MA. This role provides on-the-floor quality operations support, manages the master batch record lifecycle, and offers technical quality guidance for manufacturing event investigations. The position involves reviewing and approving complex deviations, supporting pre-approval inspections, and managing CAPA records. The Associate Director will also serve as a QA reviewer for change control records and support quality system reports.

Requirements

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.
Demonstrate capability of interpreting and adapting various technical reports in support of Investigations/Deviations.
Demonstrate capability of writing Investigation summaries in a concise and clear manner.
Strong understanding of industry regulations such as CFR, USP, EP, JP.
On the floor Biologics experience in a GMP environment required.
7+ years of leadership/management experience in an Operations, Manufacturing Technology or Technical Quality professional role.
BS/BA Degree (Biological or Chemical Science Preferred) + 9+ years of relevant experience OR Masters Degree (Biological or Chemical Science) + 8+ years of relevant experience.

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