Quality Operations Manager

Simtra BioPharma Solutions•Bloomington, IN

8h•Onsite

About The Position

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 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. This role: The Manager I, Quality role is primarily responsible for managing and assisting with site metrics associated with nonconformances, right first time, and on time delivery. The role will assist site leadership in response to any issues impacting batch release in order to assure customer needs are met. The manager will report to the Head of Quality Assurance and may act as back-up to the Quality Assurance leadership team, as needed. Must have a thorough understanding of aseptic processing and an aptitude for technical writing. This is primarily a weekend in-person role (Friday – Sunday), but due to the operational cadence required at a 24/7 facility, the role may require some flexibility depending on site needs.

Requirements

Bachelor’s degree required, preferably in Science, English, Business, or Communications
Minimum 7 years pharmaceutical industry experience
Previous leadership experience preferred
Preferred 2 years of direct Quality experience, ideally with direct NCR/CAPA management experience.
Excellent communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Maximo, Trackwise, etc.)
Duties may require overtime work, including nights and weekends.
Use of hands and fingers to manipulate office equipment is required.
Position may require sitting or standing for long hours of time.
Ability to gown (Grades A/B and C/D areas).

Responsibilities

Site Subject Matter Expert (SME) for aseptic processing, providing support to internal and external customers to ensure compliance with corporate and regulatory guidelines.
Support day-to-day operations by attending and providing decision-making at meetings focused on site metrics.
Review/Approve/Author deviations and corrective/preventative actions, manage quality segregations/holds, ensure appropriate responses to common manufacturing issues, coach site investigators and operational teams.
Participate in, or lead, change controls.
Responsible for making and delivering accurate and timely quality decisions that impact site metrics.
Support internal, regulatory and client audits, as needed.
Act as back-up to Quality Assurance leadership team, as needed.
Work with multiple departments in order to drive results.
Lead continuous improvement activities to maximize business results.