For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simtra BioPharma Solutions:

The Director of Quality Systems is responsible for managing pharmaceutical quality systems governance. The Director of Quality Systems will manage all quality systems, governance and continuous improvement as it relates to Quality Management Systems for execution of contract development and manufacturing operations on behalf of Simtra's Indiana client base.

What you'll do:

• Director is responsible for providing leadership and strategic direction in the development, implementation, and maintenance and governance of quality systems and documentation, as well as other process improvement initiatives, in compliance with GxP regulations
• A successful candidate will possess a strong background in regulatory compliance, expertise in quality management systems and document control processes, attention to detail, and the ability to collaborate cross-functionally and communicate effectively
• Provide leadership and daily management of the quality systems, document control function, and supplier quality functions ensuring alignment with company goals and objectives
• Support GxP functions by developing and implementing policies, procedures, and processes to ensure compliance with regulatory requirements
• Provide leadership and guidance to staff, promoting a culture of quality and compliance throughout the organization, be a role model for doing the right thing and delivery of quality at the speed of business, and strong analytical and influencing skills as a member of the Site Quality Leadership Team
• Responsible for QA oversight for health, use and control for management and use of the electronic Quality Management systems at Site
• Collaborate with cross-functional teams to ensure the successful quality initiatives and integration of quality systems, and documentation into all aspects of the organization.
• Conduct risk assessments and gap analyses to identify areas for improvement in quality systems and documentation practices
• Monitor the performance of the quality management system through the use of key performance indicators (KPIs), metrics, effectiveness checks, and management review to identify trends and areas for improvement
• Host the Quality Management Review, and establish and measure associated metrics, for the holistic governance and documentation of quality oversight
• Responsible for the management of audits (internal and client) and regulatory inspections, commitments, and risk management
• Provide support during Client and Internal audits and regulatory authority inspections.
• Develop and implement programs to improve internal quality systems. Foster continuous improvement efforts and culture
• Manage a large quality team
• Define department goals and metrics
• Manage department contract negotiation and review for vendors and contract staff

What you'll bring:

• Bachelor's degree in chemistry, organic chemistry, biochemistry, or other relevant scientific discipline, or above 20 years relevant Quality experience in Pharmaceutical including demonstrated success at Senior Quality leadership level; advanced degree preferred
• 10 years of QA experience in the pharmaceutical industry or a combination of pharmaceutical and other related FDA/EU regulated industry
• Experience with a range of dosage forms, including biologics, liquid sterile, and lyophilized product
• Demonstrated experience in selecting, implementing, and managing electronic Quality Management Systems
• Knowledge of GxP regulations, with prior experience supporting GMP operations (e.g. reviewing batch records, managing quality events)
• Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams
• Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization
• Strong analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner
• Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement
• Progressive management experience in pharmaceutical quality, ultimately leading a quality team of significant size
• ASQ certification preferred
• Six Sigma
• GMP QA experience
• A depth of FDA-facing experience in managing both internal audits and external audits and inspection
• A track record of accomplishment in managing multiple competing priorities on tight timelines

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Equal Employment Opportunity

Simtra is 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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