Phathom Pharmaceuticals is a late clinical-stage biopharmaceutical company committed to transforming the treatment landscape for people suffering from gastrointestinal (GI) diseases related to acid. Our initial product candidate, Vonoprazan, is a potassium competitive acid blocker (P-CAB), a new class of anti-secretory medicines with potential applications in GI diseases.
We are a team of highly driven pharmaceutical professionals who are passionate in our mission to address unmet needs for patients and improve their quality of life. We are looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced start-up environment and contributing to our growth.
Quality and Compliance
The Director, Quality Management Systems and Compliance helps manage the overall Quality Management System (QMS) and the overall company compliance to regulatory requirements and commitments. The role assures that the Quality Management System process and procedures will be in alignment with FDA 21 CFR Part 11, 210, 211 and 820 as well as associated ICH and FDA guidance, where applicable and Phathom and associated contracted companies maintain compliance. This role will additionally support area change control and IT system qualification. This position will also be responsible for managing the internal and external audit program and associated quality metrics of the organization. Other responsibilities may be incorporated and/or transitioned as the organization expands.
Support the quality and compliance activities associated with regulatory operations and submissions as well as in partnership with SMEs in other R&D areas, for business processes and systems. Works to assure compliance with clinical and associated reporting requirements. This position will assist in GPRD (General Data Protection Regulation) compliance with management and the legal team.
This function is part of a matrix organization and therefore partners with several functions and senior leadership to assure compliance to local, US FDA, EMEA, and Health Canada requirements for clinical and commercial product.
Responsibilities will include, but are not limited to, the following:
- Supports the company in assuring it is operating in accordance with applicable regulations, standards and guidance related to clinical and commercial activities and helps maintains positive audit results
- Creates the development, maintenance and improvements to the overall quality management system, including but not limited to procedures, documentation, excursion management, auditing, risk assessment/mitigation, validation, vendor qualification, customer complaints and regulatory communications related to product quality
- Provides support in issue escalation, resolution and prevention
- Manages the assignment of and adherence to the quality training program
- Escalates significant issues related to product quality, violations or non-compliance to requirements and regulations as appropriate.
- As necessary, provides communication to and interacts with government agencies, healthcare organizations and medical professionals
- Manages all internals QMS procedures to ensure they are implemented and maintained as needed for compliance with all regulatory and local requirements
- Manages the overall Change Control Program within clinical and commercial operations
- Serves as a Quality resource for vendors and contractors as needed during investigations into quality events
- Responsible for all internal and supports vendor related audits and qualification
- Supports Quality training activities, including annual GMP training
- Supports the qualification and/or validation of electronic quality systems for use and are updated as necessary
- Oversees field alert reporting and any necessary market action for the company, coordinating with leadership, contractors and vendors to ensure compliant handling of products under investigation.
- Prepares and implements audit plans for all CMOs/CTLs
- Develops and maintains the internal and external (CMO) quality metrics for Phathom
- Supports compliance to GDPR requirements
- Manages regulatory inspection readiness
- Helps manage the excursions system(s) in support of document change control and excursion management
- Encourages a companywide quality culture
- As required, manages employees or reports in support QMS and compliance requirements
- Supports efficiency initiatives that do not impact compliance
- Bachelor’s degree required; Advanced degree preferred
- Minimum of 10 years of experience in an FDA regulated pharmaceutical company
- Minimum of 4 years managing quality professionals and/or leading matrix teams
- Previous experience in agency interaction and audits
- Strong expertise in process development, Quality Management Systems and Compliance
- Experience in third party quality vendor selection, qualification and lifecycle management
- Experience in auditing within the pharmaceutical, biotech and/or oncology industry
- Proven ability to successfully interact in a matrix environment, defining objectives and scope
- Ability to execute on and manage multiple critical projects/issues simultaneously
- Some experience working within electronic quality systems, preferably in support of system validation/qualification
- Fosters long term collaborative relationships within and outside of the quality and compliance team
- Excellent interpersonal, verbal and written communication skills
- Ability to interpret data as well as write and understand routine and technical documents
- Demonstrated project management skills, including team development and execution of commitments
- Demonstrated support of efficiency initiatives within the quality/compliance area
- GDPR experience preferred
- Routine demands of an office-based environment
- Ability to travel to various meetings including overnight trips; international travel will be required
- May require approximately up to 10-30% travel
- Ability to tour and observe manufacturing, storage, distribution and testing facilities
To apply for this opening, please submit your resume to firstname.lastname@example.org and note the position for which you are applying in the subject line.