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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
true
Associate Director, Quality Assurance Operations
Posted: 11/11/2025
2025-11-11
2025-12-15
Employment Type:
Contract
Job Category: Quality
Job Number: 4744
Job Description
The primary responsibility is the Quality oversite for a manufacturing area such as Drug Substance. The role will provide "on the floor" oversite of downstream purification manufacturing activities. These activities include "on the floor" guidance during unexpected events, batch record review, room clearance, and deviation, change control management and drug substance disposition support activities.
You will partner with Manufacturing, Facilities, MSAT, Validation, and Quality Control to support manufacturing and product release activities or ongoing projects/initiatives. You will provide quality expertise to ensure compliant manufacture of GMP material (clinical or commercial). Operational excellence initiatives must be supported and driven from this level. Direct supervisor and guidance is limited but may be required more frequently to clarify directions/priorities.
Responsibilities:
You will partner with Manufacturing, Facilities, MSAT, Validation, and Quality Control to support manufacturing and product release activities or ongoing projects/initiatives. You will provide quality expertise to ensure compliant manufacture of GMP material (clinical or commercial). Operational excellence initiatives must be supported and driven from this level. Direct supervisor and guidance is limited but may be required more frequently to clarify directions/priorities.
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; ask the tough questions.
- 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
- You will have 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.
- You will 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.
- Direct supervision and guidance is minimal but may be required to clarify directions and priorities.
- Strong understanding of industry regulations such as CFR, USP, EP, JP
- On the floor Biologics experience in a GMP environment required
- Demonstrates strong quality judgement in various situation when making decision
- 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
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