Associate Director, Quality Operations

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.

Why join Team Simtra Because we:

Make it HAPPEN We bring a growth mindset to every opportunity developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER We work as one respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.

Make it COUNT We take pride in our day-to-day work knowing the impact we make taking on challenges big and small to improve patient health.

The role:

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.

Role/Decision Scope:

• 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:

• 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:

• Bachelors 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:

• 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 youll be eligible for1:

• 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
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

1 Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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