Spirovant Sciences, Inc. is recruiting a Director, Quality responsible for directing and coordinating one- two GXP discipline(s). The position is responsible for independently performing domestic and international audits/inspections for Spirovant client groups that ensure compliance to the FDA and other worldwide health authority regulations /guidelines, site SOPs, protocols, and industry standards, as applicable. This includes applying developed skills to assure management that the facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with applicable regulations.
This position provides recommendations for corrective action and tracks corrective action commitments until closure. Further, this position will work with the Acting Head of Quality to set the vision and direction for the Company’s Quality function. The ideal candidate will be comfortable in a results-driven, highly accountable environment where you can make an immediate impact.
· Applies established quality skills in Good Manufacturing Practices (GMPs) applicable to clinical supplies or commercial manufacturing of combination products, and (D) Good Pharmacovigilance Practices for product complaints (GVPs) appropriate for clinical trials and commercial product.
· Supports the build of a quality management system (i.e., quality standards and processes) that are appropriate to company size and growth.
· Develop strong collaborative relationships with all functional departments of the Company.
· Leads internal discussions pertaining to internal and external GMP quality issues.
· Serves as the point-person for GMP discussions with external CDMOs.
· Communicates in an open, clear, complete, timely and consistent manner.
· As required, interfaces with regulatory agencies on matters pertaining to processes, products or Quality systems related to GMP compliance. Provides support during regulatory inspections and audits.
· Ensures products manufactured at CDMOs meet company quality standards and government regulations through Sponsor Quality review of CDMO records and reports (i.e., Master Batch Records, Executed Batch Records, Certificates of Analysis (CoAs) and associated testing, Out of Specification (OOS)/Out of Trend (OOT)/ Out of Expectation (OOE) investigations, etc.).
· Performs Sponsor Quality release of batches.
· Plans and conducts domestic and international audits, as needed.
· Conducts qualification audits and reviews qualification audit reports, as appropriate.
· Provides guidance for recommendations of corrective and preventive actions (CAPAs) pertaining to quality concerns. Develop resolution of quality concerns and reviews implementation of CAPAs.
· Reviews metrics and trends as well as compliance issues and their resolution on a periodic basis and works with the GMP functional departments to achieve continuous process improvement.
· Informs, mentors and trains internal employees and, if necessary, external consultants and is responsible for ensuring the adequate training records are maintained for internal employees and consultants, as required.
· Minimum Bachelor’s Degree in in the life sciences.
· 10+ years industry experience with
· 8+ years of experience in, quality assurance, quality systems, and/or compliance role with increasing responsibility in a pharmaceutical or biotech company.
· Extensive knowledge of and in-depth experience with GMP regulations pharmaceutical manufacturing environments for USA, EU and other global health authorities.
· Direct experience in performing Sponsor Quality reviews for release of drugs/devices
· Direct experience in resolving Invalid assays and Out-of-Specification/Out-of-Trend leading to successful re-tests
· Experience with participating in government regulatory audits and inspections.
ADDITIONAL DESIRED QUALIFICATIONS:
· Experience working in a biotech with a biologic, gene therapy or advanced cell therapy products
· Drug-device combination product experience (inhalation devices)
· Experience providing Quality oversight of medical device suppliers (i.e. manufacturers and testing facilities, etc.)
Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.