Associate Director of QA

Simtra Bio Pharma 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  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.

• 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 teams-so we can solve problems in new ways.
• Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling 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 Associate Director of Quality Assurance, is a member of the Quality Assurance Leadership Team reporting directly to the Quality Director. He or she provides leadership and direction for Filling Quality Line Operations and Finishing Quality Line Operations. The Associate Director provides decision making and oversight to ensure compliance to all standard operating procedures for areas of responsibility. He or she must fully support and drive quality operations, communicate effectively with production team members, multiple levels of management, and other customer support departments.

The Associate Director creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

• Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations.
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Creates/Develops a strong team by setting clear direction and empowering members to obtain results that support strategic objectives.
• Develops department annual budget and ensures spending within expected quarterly forecasts.
• Plan, organize, direct, and evaluate applicable activities to ensure the safety and reliability of manufactured products.
• Responsible for ensuring compliance to plant procedures, corporate quality policies, Federal and European regulations, and guidance.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production, and other support functions as necessary to meet plant and department goals/objectives.
• Ensures training compliance for QA team.
• Supports QA oversight of Aseptic Filling operations, Inspection, Labeling and Packaging operations, and Warehouse operations, including finished product reserve sample inspection, finished product sampling, and shipping.
• Participates in escalated client issue resolution (conference calls, client visits, audits).
• Responsible for tracking and trending Quality data for review and reporting.
• Lead teams in continuous improvement project activities.
• 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.
• Review and Approve…