The Company: Object Pharma owns Clostridium botulinum serotypes A through G and has a pipeline of neurotoxin candidates that will expand the clinical application of neurotoxins.
Our employees have the unique opportunity to develop broad expertise in a small, inclusive company.
We believe that every member is critical to building a strong company and generating superior products.
The Position: Object is searching for a Quality Manager who will be responsible for QA/QC and regulatory compliance of Object’s Madison site. The position will be based in Madison, WI and will report to the Site Head. The Quality Manager will work closely with corporate Quality, Regulatory, and related functions located in California.
Be an integral Quality partner in Object’s drug development activities and reagent manufacturing
Establish and maintain a phase-appropriate Quality Management System
Implement a document control process to draft, review, approve, issue, maintain, and archive GMP documents and records
Proactively identify and communicate issues and risks; work together with management and SMEs to develop plans to address and/or mitigate
Coordinate and manage the handling of change controls, deviations, investigations, complaints, CAPAs, etc.
Host and/or participate in regulatory inspections and quality audits of the site
Ensure inspection & audit findings are adequately addressed and closed per agreed timeframes
Qualify and maintain quality oversight of vendors, suppliers, and contract partners
Review and negotiate quality agreements
Work with manufacturing and site leadership to plan and coordinate batch production and testing activities
Perform Person-in-Plant activities as necessary
Review batch production records, including test results, and identify any discrepancies
Perform batch disposition activities in support of lot release
Review and approve stability protocols, data, and reports
Prepare Annual Product Reviews (APR) as required
Identify opportunities for continuous improvement and support site or corporate initiatives to enhance systems
Maintain awareness of new or evolving regulatory-compliance requirements and develop plans to address gaps
Identify country or region-specific Quality requirements in support of Object’s product development plans
Represent Object Pharma in a professional manner with internal and external team members, business associates, and regulatory authorities
Ability to operate under pressure, manage multiple ongoing tasks while consistently delivering timely and quality results
Strong problem-solving and analytical skills
Ability to lead projects involving multiple stakeholders, collaborate and communicate effectively, and balance divergent inputs while continuing to move forward
Ability to operate in a growing company with site, functional, and executive leadership
Ability to travel +/- 10% to external sites
Bachelor’s degree in a scientific discipline.
Prior experience in a Quality or Manufacturing role in an FDA-regulated environment.
Thorough understanding of cGMP regulations and expectations
Team player with demonstrated willingness to learn new skills across relevant specialties to fit the broad needs of a small biotech
Physical ability to work regularly in a laboratory environment, including walking/standing for long periods of time, using standard laboratory equipment, using standard office equipment, and occasionally lifting up to 40 pounds
Employees must pass a background check and receive CDC approval to work with select agents and toxins. Previous CDC approval is a plus
The Location: This position is located at Metabiologics in Madison, Wisconsin.
Equal Employment Opportunity
Object Pharma is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to any legally protected characteristic in compliance with U.S. and State of Wisconsin employment laws.
About Object Pharma, Inc.
Object Pharma is a biotech company located in Aliso Viejo, California, with GMP facilities in Madison, Wisconsin. Object is developing novel neurotoxin products for aesthetic and therapeutic applications. We offer our employees competitive compensation, a flexible, fast-paced environment, and the opportunity to learn a diverse skill set in an expanding company. We are an equal opportunity employer.