Quality Assurance Manager

BioHybrid Solutions LLC (BHS) is a Carnegie Mellon University spin-off, focused on next generation protein-polymer therapeutics as alternatives to PEGylation. We are a fast-growing company with a network of committed partners and collaborators. We are looking for an ambitious and motivated candidate for a role of Quality Assurance Manager. The Quality Assurance Manager will bring a proven track record in the development and manufacturing of biologics drugs to the company and will be primarily responsible for driving our growth from preclinical development to a clinical product.

Job Description

BioHybrid Solutions (BHS) is looking for a Quality Assurance Manager with experience in biologics-based therapeutics development. The Quality Assurance Manager will report to the Senior Director of Quality and Operations.

• Responsible for collaborating with management to set strategic quality plans for BHS operations.
• Partners in the development of the Quality Plan for cGMPs and ensures deployment as approved by BHS senior management.
• Responsible for supporting quality oversight for components and/or products manufactured by external contract manufacturing organizations (CMOs), including audits, quality assurance, quality control and analytical issues.
• Supports the creation and implementation of QA Agreements at third party sites. This includes an annual audit of third-party manufacturing sites.
• Supports deployment and implementation of GxP practices, policies and procedures within the BHS laboratory.
• Manages quality events including change control and incident reporting. Lead root cause analysis investigations and develop CAPA for continuous improvement. 
• Work with BHS’s analytical team to support design of experiments (DOEs), qualification studies and phase appropriate validations.
• Manage vendor qualification.
• Manages the electronic Quality Management System which include controlled documents, training, change control, Incident Reporting and CAPA.
• Develop and implement quality indicators to trend the quality programs success.
• Provides quality input in technology transfers to CMOs.

Required Qualifications:

• B.S. or M.S. degree in the Life Sciences (or equivalent) with a minimum of 2 years of cGMP QA experience.
• Demonstrated experience with FDA, client, or 3rd party audits.
• Demonstrated experience reviewing protocols, batch records and SOPs.
• Demonstrated experience conducting and/or directing audits and inspections.
• Proficient written and oral communication skills.
• Leadership abilities with strong problem-solving ability.
• Ability to work well with others in a fast-paced environment.
• Well organized and methodical.
• Flexible in adjusting priorities and able to take risks to accomplish goals.
• Ability to effectively communicate expectations.
• Ability to gain acceptance of an idea, plan, or activity.
• Ability to interact with technical staff at all levels in a team-based environment.

BioHybrid Solutions is an equal opportunity employer without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other applicable federal or state protected classification.