Director Quality Systems

Albireo Pharma Overview:

Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo has deep expertise in bile acid biology and a pipeline of clinical and pre-clinical programs. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 pivotal trials in PFIC, Alagille syndrome and biliary atresia. The Company completed IND-enabling studies for new preclinical candidate A3907 and plans to advance development in adult liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year.

The company’s first commercial launch will be odevixibat, which is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC.

The FDA has granted Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of July 20, 2021. Odevixibat previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. In Europe, the Company has submitted odevixibat for a Marketing Authorization Application (MAA) to the EMA seeking approval in PFIC. Odevixibat is the only IBATi granted accelerated assessment by the EMA. It has also been granted Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of ALGS, biliary atresia and PBC. With U.S. and EU regulatory filings in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease Priority Review Voucher and launch in the second half of 2021.

Odevixibat is also currently being evaluated in a Phase 3, long-term extension study and two pivotal Phase 3 trials: the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, the BOLD Phase 3 trial in patients with biliary atresia and the ASSERT Phase 3 trial in ALGS. Albireo is also exploring multiple methods for modulating bile acids to significantly change the bile acid transporter approach in adult liver disease, with two promising new candidates with two different mechanisms of action. The Company will initially focus on primary sclerosing cholangitis (PSC) and primary bilateral cholangitis (PBC) as well as viral cholestatic liver disease, including hepatitis B and D.

Job Summary

Responsible for the development, management and continuous improvement of Quality Systems at Albireo to ensure its products and processes are compliant to regulatory, functional area and customer requirements. Partner with all areas of the business to understand and address their needs/issues. Interface with all areas of the business to elevate potential issues to management and drive continuous improvement efforts. Provide expertise and leadership in implementing a quality system management function for clinical and commercial products.

Essential Functions:

• Provide Expertise on implementation and maintenance of the Quality Management System (QMS), both electronic and paper based, including but not limited to SOPs, document control, product complaints, training, change management and quality event management (deviations and CAPAs)
• Develop, implement and manage an integrated viewpoint for the Quality System
• Develop Quality System (GXP) including GDP procedures and administer documents for both clinical and commercial operations that are compliant and fit for purpose. Create, implement and manage key performance and Quality indicators (KPI and KQI) and metrics/dashboards to assess QMS and contract service provider (CSP) performance and present at periodic internal management meetings and joint steering committee (JSC) meetings with the CSP management.
• Provide guidance for computer system validation plans and summaries in accordance with the SDLC (Software Development Life Cycle) and Part 11/Annex 11 and review/approve all computer system validation deliverables that directly affect Albireo functions.
• Facilitate continuous improvement initiatives aimed to increase efficiencies
• Manage the inspection process for regulatory and partner audits and responses to audits.
• Ensure and manage the vendor qualification process.
• Support, as subject matter expert, for regulatory and partner audits
• Ensure effective and timely Quality support of commitments to corporate timelines, milestones and regulatory requirements
• Partner with functional teams to identify, administer and implement optimized system designs for document management, change control, specifications, deviations and CAPAs and training.
• Manage Internal audit program and process improvements for Quality Systems
• Actively influence and participate on Quality initiatives from a strategic compliance perspective
• Develop/enhance and manage training program, including annual GMP training.
• Direct, manage, provide guidance and develop staff
• Maintain the corporate Quality Manual

• Review, comment, and approve if required Quality agreements with partners and vendors
• Participate on project teams as assigned.

• Responsible for input to budget in functional area.

Position Requirements:

• Bachelor or Advanced degree in science or equivalent experience
• Relevant Quality experience
• Min. 12 years direct experience in the Pharmaceutical, Biotechnology or related industry
• Extensive knowledge and understanding of global requirements for cGXP and quality systems for clinical and commercial manufacturing and supply, and ability to apply said knowledge to sound quality decisions
• Excellent verbal and written communication skills, good interpersonal skills, detail oriented and ability to work across functions
• Excellent critical thinking skills to interpret external regulatory/compliance documents and internal metrics to propose appropriate mitigation
• Working knowledge of software solutions for QMS
• Excellent leadership skills and a history of developing subordinate quality professionals
• Ability to travel 15-20%.