About the Role >>> Associate Director, GMP Quality – Qualified Person

As the Qualified Person (QP), reporting to the Senior Director, Quality Assurance based in San Francisco, California, USA you will hold responsibility for ensuring that Clinical and Commercial medicinal products are manufactured, tested and released in compliance with applicable regulatory requirements of the European Union. You will also ensure that the products are prepared for certification by QPs of the United Kingdom and Israel and are compatible with U.S requirements.

You will be responsible for conducting Supplier and Contract Service Provider audits within the European Economic Community and other geographies. You will monitor changes to European regulatory requirements and host any inspections conducted by the Health Product Regulatory Authority (HPRA) or other Competent Authorities of the European Union. You will be an integral participant in annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews (APRs) following commercial launch. You will work closely with our European CDMOs may also support the processing of European Product Complaints.

This role is based out of our Dublin, Ireland office location and will require up to 25% travel, including some international.

Your work will primarily encompass:

Batch Certification

• Ensure all manufacturing and testing activities comply with approved procedures, Investigational Medicinal Product Dossiers and regulatory standards
• Ensure that outsourced manufacturing and testing activities meet GMP and quality standards
• Act as the legally accountable person for batch certification (as per Directive 2001/83/EC, where applicable)
• Certify and release batches of medicinal products in accordance with EU GMP, Marketing Authorization (MA), and regulatory requirements

Supplier Quality Management

• In conjunction with U.S. based Compliance functions, provide Supplier and CSPs quality and compliance oversight
• Establish appropriate assessment mechanisms, risk-based controls, and monitoring and feedback loops to ensure compliant, effective oversight
• Serve as a resource for the conduct of audits and other assessments of both suppliers and business partners
• Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)

And will also include:

Inspection Readiness

• Establish and maintain the infrastructure and processes required to prepare Olema’s European affiliate for HPRA and other Competent Authorities of the European Union
• Utilize electronic systems, including Artificial Intelligence–enabled tools, to support inspection readiness activities
• Utilize Inspection Management Software to ensure consistent and reliable inspection preparation and response
• Perform Mock Inspections at European Suppliers / CSPs / Partners

Regulatory Intelligence and Monitoring

• Monitor local and European regulatory authorities for proposed GMP rulemaking and or trends in regulatory inspections
• Monitor inspectional status and compliance trends within the Olema European Supplier and CSP network

Annual Reviews and Quality System Leadership

• Participate in the annual Quality Management Review process
• Participate in the execution of Annual Product Quality Reviews upon commercial product launch
• Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions on European topics

As this is a new office, there may be other assignments and projects as required.

Ideal Candidate Profile >>>

A strong contributor with in-depth knowledge. A confident professional with a solid understanding of EU and UK regulatory GMP compliance requirements. A team-oriented individual with solid ability to communicate across multiple time zones, strong work ethic, optimism, and commitment to meaningful contributions. As such, we are looking for someone with the right combination of qualifications, knowledge, experience, and attributes for this role.

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Qualifications

• Eligible to act as a Qualified Person under EU legislation (Directive 2001/83/EC)
• Pharmaceutical Quality System (PQS) Auditor certification is highly preferred

Knowledge

• Bachelor's degree in pharmacy, chemistry, biology or a related scientific field is required
• Strong understanding of EU and Rest-of-World (ROW) regulatory and compliance requirements
• Demonstrated experience in Supplier Compliance and Inspection Management
• Firm knowledge of GMPs, GDPs and Quality Management Systems
• Experience using Inspection Management Software

Experience

• Minimum 10 years of experience in Biopharmaceutical industry
• Minimum 7 Years of experience in Supplier Quality Management
• Minimum 3 Years of experience with Oral Solid Dosage forms
• Minimum 4 Years of experience in a Qualified Person role
• Oncology experience is desirable

Attributes

• Self-directed and capable of independently setting and managing priorities
• Able to adapt to a rapidly changing organization characterized by ambiguity and evolving process definition
• Demonstrates strong cross-functional collaboration, and communication skills
• Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
• Critical thinking, able to identify the gates required for QP certification
• Passionate about meaningful work and contributing to patient-focused outcomes

#LI-MK1

Purpose of Role 

The Operational Risk Associate will be part of the wider Enterprise Risk / Operational Risk function and support the team in further developing and managing operational risks across all business functions.

The position will report to the Head of Enterprise/Operational Risk.

Key Responsibilities  

• Support the development and implementation of Pantheon’s global operational risk frameworks and policies and procedures for adoption by Pantheon Group entities
• Support the ISAE 3402/SSAE 16 annual processes including completion of the document, drafting of controls wording and providing external auditor with supporting information.
• Support process and control reviews to identify risks and issues in Pantheon’s control environment. Reviews will include identified areas of risk, monitoring programme and new business processes.
• Manage Error/Incident reporting process including reporting to management and resolution of any issues. Ensure monitoring procedures are in line with Pantheon’s risk policies. Direct investigation of serious error or breaches and make recommendations for change to management
• Co-ordinate and assist in providing risk oversight and governance across third party supplier relationships of all Pantheon Group entities
• Support business continuity process including BCP and testing programme.
• Support to manage various risk-related frameworks such as the data privacy / data protection, vendor risk, Insurance risk, and assist with any client / business related queries
• Support and further develop a centralised library of processes, risks and controls in a strategic risk system

Skills and Experience Required  

• Degree level education
• Experience of working in a risk function ideally in an investment banking, asset management, private equity environment
• Understanding of investment management and products
• Ability to work on own initiative and in team
• Ability to identify when issues should be escalated for further discussion
• Controls awareness
• Keen problem-solving skills, ability to offer solutions to issues

#LI-SB1

About the Role

We are seeking an experienced Senior Accounts Receivable Analyst to join our Finance team in Dublin, reporting directly to the International Revenue Accounting LEAD in Dublin with a dotted line to the Global Process Owner in the US. In this role, you will be responsible for the day-to-day collection’s activities for all EMEA-based customers, ensuring timely cash application and dispute resolution across the region. This role plays an important part in ensuring global consistency by following Anthropic’s global credit and collections policies and maintaining key KPIs in line with the rest of the organization. You will serve as a key cross-functional partner to Sales, Legal, and Customer Success teams, while driving process improvements to scale AR operations as Anthropic continues its rapid growth.

Responsibilities:

Collections & Cash Application

• Manage end-to-end collections for EMEA customers, proactively contacting accounts to ensure timely payment in accordance with agreed terms.

• Monitor aging reports daily, prioritize outreach based on balance, risk, and strategic importance, and maintain DSO targets for the EMEA portfolio.

• Ensure accurate and timely cash application, investigating and resolving unapplied or misapplied payments.

• Prepare and distribute customer account statements and payment reminders on a regular cadence.

Dispute Management

• Investigate and resolve billing disputes, short payments, and customer queries in a timely and professional manner.

• Collaborate with Sales, Customer Success, and Legal to resolve complex disputes, including contract interpretation issues and pricing discrepancies.

• Track dispute trends and root causes, providing insights and recommendations to reduce future occurrences.

• Maintain detailed records of all dispute activity and resolutions for audit and reporting purposes.

Cross-Functional Partnership

• Serve as the primary AR point of contact for EMEA Sales and Customer Success teams, providing account-level insights and supporting deal structuring with payment terms guidance to the Credit and Deal Desk teams.

• Partner with Legal on contract terms impacting receivables, including payment clauses, late-payment provisions, and currency considerations.

• Collaborate with Revenue Accounting and FP&A on cash forecasting, revenue recognition support, and month-end close activities.

• Support external audit requirements by preparing AR-related schedules and responding to auditor inquiries.

Global Consistency & Compliance

• Adhere to and champion Anthropic’s global credit and collections policies, ensuring EMEA operations are fully aligned with worldwide standards and procedures.

• Maintain key AR performance KPIs (DSO, aging buckets, collections rates, dispute resolution time, etc.) in line with global benchmarks and targets.

• Participate in regular global AR reviews with the US-based team, providing EMEA performance updates and aligning on policy changes or process enhancements.

• Ensure consistent application of payment terms, escalation protocols, and customer communication standards across all EMEA markets in accordance with global guidelines as well as local practices.

• Partner with the Global Process Owner on the rollout or modification of policies, tools, and initiatives for EMEA for adoption and effectiveness monitoring.

Process Improvement & Systems

• Identify opportunities to automate and streamline AR workflows, including collections outreach, cash application, and reporting.

• Contribute to the evaluation, implementation, and optimization of AR tools and technologies (e.g., ERP systems, collections platforms, dunning automation).

• Maintain AR Policies, procedures & SOX-Compliant controls for the EMEA region, aligned with global standards.

• Manage and update dashboards and reporting to provide visibility into EMEA AR performance, including DSO, aging, and collections effectiveness metrics.

You may be a good fit if you have:

• 7–10 years of progressive experience in accounts receivable or order-to-cash operations, preferably within a high-growth technology or SaaS company.

• Deep expertise in B2B collections across multiple European jurisdictions, with strong knowledge of local payment practices, regulations, and cultural nuances.

• Proficiency with ERP, Billing & Collections systems (e.g., NetSuite, Stripe, Workday, Zuora, Tesorio, HighRadius) and advanced to expert level Excel/Google Sheets skills.

• Strong understanding of IFRS revenue recognition standards and their impact on AR processes.

• Understanding of expected credit loss methodologies (IFRS 9 and CECL) and their application to accounts receivable, including the ability to support reserve calculations and provide data inputs for loss modelling.

• Excellent communication and negotiation skills, with the ability to engage diplomatically with customers at all levels.

• Demonstrated ability to operate within a global framework, adhering to centralized policies and KPI targets while adapting execution to local market requirements.

• Proven ability to work independently, manage competing priorities, and meet deadlines in a fast-paced environment.

• Bachelor’s degree in Finance, Accounting, Business Administration, or a related field.

Strong candidates may have:

• Professional qualification (ACA, ACCA, CIMA) or equivalent certification.

• Familiarity with Salesforce CRM and its integration with billing/AR systems.

• Experience operating across multiple currencies and managing FX-related AR complexities.

• Prior experience building AR processes from the ground up in a scaling organization.

• Fluency in one or more additional European languages is a strong plus.