Sr Manager Clinical QA, Quality and Compliance

Phathom Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of gastrointestinal (GI) diseases. With exclusive rights in the United States, Europe, and Canada to vonoprazan—a first-in-class potassium-competitive acid blocker (PCAB)—Phathom is working to transform the treatment of acid-related disorders.

Our current portfolio includes:

• VOQUEZNA® (vonoprazan) tablets, approved for the treatment of heartburn associated with Non-Erosive GERD, as well as the healing and maintenance of healing of Erosive GERD
• VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules), approved for the treatment of H. pylori infection in adults

Beyond our commercialized products, we are advancing a pipeline focused on innovative treatments for other acid-related GI disorders, including Eosinophilic Esophagitis (EoE).

At Phathom, we are fueled by innovation, driven by purpose, and united by a shared commitment to improving patient outcomes. Our team comprises seasoned GI and industry experts with proven track records of delivering groundbreaking therapies, including anti-secretory agents. Together, we are tackling unmet medical needs and working hard to enhance the lives of patients.

We seek motivated, innovative problem-solvers who excel in fast-paced, collaborative environments and are eager to make an impact. At Phathom, you’ll find more than a career – you’ll join our “Phamily,” where employees feel empowered, valued, and inspired to do their best work.

In July 2024, we proudly earned the distinction of being Great Place to Work® certified, with 89% of surveyed employees affirming that Phathom is an exceptional workplace.

Ready to help change the landscape in GI? Join us and be part of something extraordinary.

Job Summary

The position helps manage the overall Phathom Quality Management System (QMS), and assures compliance with applicable regulations, standards, and guidance related to clinical and commercial activities. The role assures that the Quality processes and procedures are in alignment with FDA 21 CFR Parts 11, 210, and 211 as well as applicable ICH and FDA guidance at Phathom and external vendors. This position is responsible for managing key elements of the quality program, batch record review, Deviation & CAPA review, change control, product complaints, Field Alert, Recall, vendor management, and Annual Product Review. The role will support regulatory inspection readiness and remediation. Other responsibilities may be added as the organization expands.

ACCOUNTABILITIES

• Leads clinical quality support activities as follows:
  • Attend regularly scheduled update meetings with CRO, CRL, internal with Dev-Ops, clinical study planning, and clinical study sponsor update.
  • Perform vendor assessment of clinical research organizations, clinical testing labs, and clinical sites.
  • Prepare clinical site audit plans.
  • Manages Deviations and CAPAs for clinical vendor investigations.
  • Support clinical site regulatory inspections, including site preparation, audit execution, and follow-up corrective actions.
• Performs batch record review and other product support activities (clinical and non-clinical).
• Manages change controls for commercial and clinical product.
• Leads product complaint investigation process, including management of external contact center.
• Develops and delivers training content for product complaint recognition and reporting, and regulatory inspection readiness.
• Manages internal QMS procedures to ensure they are implemented and maintained as needed for compliance with all regulatory and local requirements.
• Qualify external GxP vendors using onsite/remote audits, questionnaires, and written assessments.
• Prepares and reviews Annual Product Review reports.
• Prepares slides for Management Review meetings. Create graphs for metric trending. Develop PHocus dashboards/reports to support metrics tracking.
• Supports internal audits and external regulatory inspections.
• Support Field Alert and Recall process
• Escalates significant issues related to product quality or compliance.

EDUCATION & EXPERIENCE

• Bachelor’s degree required
• Minimum of 6 years of experience in an FDA regulated company
• Minimum of 4 years supporting quality compliance functions (batch review, change control, Deviation/CAPA, product complaints, Field Alert, Recall)
• Previous experience with regulatory agency inspections
• Experience auditing vendors within the pharmaceutical or medical device industry
• Ability to successfully interact in a matrix environment, defining objectives and scope
• Ability to execute on and manage multiple critical projects/issues simultaneously
• Experience working within electronic quality systems
• Fosters long term collaborative relationships within and outside of the QCS 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
• Experience with GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), and GCP (Good Clinical Practices) regulations
• Experience with data integrity regulations
• Prefer experience with DSCSA (Drug Supply Chain Security Act) regulations
• Prefer experience with GDPR (General Data Protection Regulation) and PHI (Protected Health Information)

Phathom’s Core Values:

• Perseverance – With hard work and determination, together we overcome all obstacles
• Humble – We put others first, remain grounded and let our work speak for itself
• Accountable – We are reliable and take personal responsibility in all that we do. We take pride and ownership in our work every day
• Transparent – We say what we mean, debate openly and respectfully, and have no hidden agendas
• Entrepreneurial – We are nimble, agile and embrace innovation. We challenge the status quo, enjoy change and approach problems unconventionally

Working at Phathom:

At Phathom, we prioritize the total well-being of our “Phamily” members. Our commitment is reflected in a competitive employee benefits package designed to support employees and their families’ overall well-being, now and in the future, including:

• Highly competitive medical, dental and vision coverage options with low monthly premiums
• Roth & Traditional 401(k) savings plan with annual employer match
• Long-term incentive equity compensation program
• Employee Stock Purchase Plan (ESPP)
• Comprehensive paid leave programs, including:
  • 16 weeks of paid parental leave for all new parents
  • 4-week part-time Bridge-Back-to-Work Program
• Hybrid and Flex Working Arrangements
• Unlimited Time Off
• 17 paid company holidays in addition to a year-end winter shutdown period

Other Benefits:

• Annual Fitness & Wellbeing Reimbursement
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Pet insurance benefits
• Company-funded HSA plan
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Paid time off to volunteer
• Employee recognition program
• Employee discounts

Annual salary range: $175,000-$190,000

Phathom is an equal opportunity employer that is committed to inclusion and diversity and provides equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics.

Applicants with a disability who require a reasonable accommodation for any part of the application, interview or hiring process can contact us by sending an email to careers@phathompharma.com.

Salary : $175,000 - $190,000