Associate Director, Quality Operations

Associate Director, Quality Operations

Bloomington, Indiana, United States

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

The Associate Director Quality Operations is accountable for end-to-end Quality Operations and quality oversight for the Focus Factory. This role is a member of the Site Quality Leadership Team and a key member of the Focus Factory Leadership Team, reporting directly to the Quality Director. The incumbent owns quality performance for the Focus Factory and ensures that operations are executed in compliance with cGMP requirements, site procedures, corporate quality policies, applicable regulatory expectations, and client commitments. The role provides strategic and day-to-day leadership across Filling Quality Line Operations, Finishing /Inspection/Labeling/Packaging Quality Operations, Environmental Monitoring sampling/support, Warehouse and shipping quality oversight as applicable, Batch Record Review, Batch Disposition/Release, deviation/nonconformance management, and CAPA. The role ensures quality decisions are made with appropriate scientific, compliance, patient safety, and business risk considerations, while driving a culture of ownership, proactive escalation, continuous improvement, and right-first-time execution.

The role/decision scope includes:

• Single point of Quality Operations accountability for the assigned Focus Factory, from manufacturing readiness through batch disposition and release.
• Provides independent quality oversight and quality decision-making for routine operations, escalations, deviations, CAPA effectiveness, and inspection readiness.
• Serves as an empowered Quality Leader and designee to the Quality Director for defined reviews, approvals, Quality Review Board endorsements, and escalation forums, as delegated by procedure or written delegation.
• Partners with other cross Focus Factory quality functions, Manufacturing, Technical Services, Engineering, Supply Chain, QC, Regulatory, and Client Services to ensure quality, compliance, supply continuity, and patient safety are appropriately balanced and documented.

The responsibilities include:

• Establish clear quality priorities, resource plans, and coverage models to support 24/7 operations, including manufacturing floor support, real-time quality decision-making, and timely escalation of quality risks.
• Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations.
• Ensure the Focus Factory quality organization operates with strong ownership, accountability, and alignment to site quality strategy, operational goals, client commitments, and regulatory expectations.
• Develops department annual budget and ensures spending within expected quarterly forecasts.
• Assess workload, staffing, and skill mix to ensure the Quality Operations organization can provide effective oversight across all shifts and operating areas.
• Participate in escalated client issue resolution (conference calls, client visits, audits).
• Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.

Quality Oversight, Compliance, and Batch Disposition

• Ensure quality oversight of aseptic filling operations, inspection, labeling and packaging operations, warehouse operations, finished product reserve sample inspection, finished product sampling, and product shipment activities as applicable.
• Ensure timely and thorough QA review of batch records and associated documentation to meet internal release targets and contractual batch release commitments.
• Verify that each batch disposition decision is scientifically justified, fully documented, compliant with procedures and regulations, and appropriately considers patient safety, product quality, SISPQ, and client/regulatory commitments.
• Provide direction for review, approval, and escalation of deviations, nonconformance reports, investigations, root cause analyses, CAPAs, and effectiveness checks related to Focus Factory operations.
• Identify, assess, and escalate emerging quality and compliance risks, including recurring deviations, quality system weaknesses, aseptic processing risks, sterility assurance risks, and trends that may affect batch disposition or supply.

Focus Factory Performance and Quality KPIs

• Own Focus Factory quality and compliance performance metrics, including right-first-time performance, deviation aging, CAPA timeliness/effectiveness, batch release cycle time, inspection readiness, training compliance, and other site-defined KPIs.
• Develop and use quality data, dashboards, and trend reports to drive performance management, proactive risk reduction, and decision-making at Focus Factory and Site Quality Leadership forums.
• Lead or sponsor continuous improvement projects that strengthen quality culture, reduce repeat deviations, simplify execution, improve documentation quality, and support reliable batch release and supply performance.
• Ensure robust management review and escalation of quality issues, including appropriate use of Quality Review Board and other governance forums.

People Leadership, Capability Building, and Culture

• Interview, hire, coach, develop, and retain a high-performing Quality Operations team; set clear expectations, performance objectives, development plans, succession plans, and accountability measures.
• Conduct performance reviews for direct reports and ensure performance management is fair, timely, evidence-based, and aligned with company expectations.
• Create an environment of teamwork, inclusion, transparency, and constructive challenge where quality decisions are made with integrity and where safety, identity, strength, purity, and quality are reflected in the finished product.
• Ensure training compliance and capability development for the QA team, including cGMP expectations, aseptic/sterility assurance concepts, deviation investigation, CAPA, batch record review, data integrity, and decision-making standards.
• Model expected leadership behaviors, including prioritization, delegation, strategic thinking, cross-functional collaboration, proactive escalation, and continuous improvement.

Required qualifications include:

• Bachelor's degree required preference in a Life Science field; advanced degree preferred.
• Minimum 8 years' experience in Quality or pharmaceutical industry experience.
• Minimum 5 years' experience in a management role.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements include:

• Must be able to qualify for entry into Class A/B aseptic facilities.
• Must wear appropriate personal protective equipment as applicable.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time.

In return, you'll be eligible for:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection

Simtra BioPharma Solutions