Deciphera Pharmaceuticals

QA Engineer

• Lead batch release activities, including review/approval of batch records and material disposition
• Provide GMP oversight for manufacturing and distribution partners (DS, DP, and supply chain)
• Ensure compliance with global regulations (FDA, EMA, ICH)
• Manage investigations, deviations, CAPA, and change controls
• Support audits, inspections, and annual product reviews
• Drive quality system improvements and track key quality metrics
• Partner with CMOs and suppliers on validation, tech transfer, and qualification activities
• Mentor and develop junior QA staff

Senior Manager, GMP Quality Assurance

Compliance

• Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures.
• Assist in coordination and preparation of global health authority meeting documents.
• Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards.
• Represents regulatory for global study-level regulatory activities included but not limited to study start-up, study maintenance, and end of trial activities.
• Collaborate with external partners and vendors on regulatory activities and submission support.
• Support regulatory operations and continuous improvement initiatives, including work instruction and SOP development and maintenance.

Manager, Regulatory Affairs

Account Manager

• Develop and execute a comprehensive territory business plan aligned with brand strategy, business objectives, and compliance requirements
• Identify, prioritize, and engage oncology accounts, including oncologists, advanced practice providers, pharmacists, and key office staff
• Deliver accurate, balanced, and approved product information, clinical data, and disease state education in a compliant manner
• Manage account interactions to support appropriate product utilization within approved indications
• Analyze territory performance data to adjust strategy and optimize call planning and resource allocation
• Collaborate with Market Access, Medical Affairs, Sales Leadership, and other internal stakeholders to support patient access and education efforts
• Communicate field‑based insights related to customer needs, market dynamics, competitive activity, and reimbursement trends
• Maintain timely and accurate documentation of customer interactions, call activity, and territory plans within the CRM system
• Complete expense reporting, sample accountability (if applicable), and other administrative requirements in accordance with company policy
• Ensure strict adherence to FDA regulations, company SOPs, and industry compliance standards, including promotional practices.

Oncology Territory Manager

• Driving commercial performance within an assigned geographic territory by developing professional relationships with oncology healthcare providers.
• Executing brand strategy at the territory level through compliant, high-quality scientific and product education.
• Supporting appropriate patient identification and access.
• Collaborating cross-functionally to deliver insights that inform business strategy.

• Draft, review or revise Clinical QA SOPs to assess consistency and compliance with regulatory requirements/internal standards.
• Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management.
• Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary.
• Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents.
• Assist and advise with training QA and clinical staff as necessary for GCP.
• Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.
• As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board.
• Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.
• Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation).
• Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.
• Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).
• Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process.
• Assist with inspection readiness, and regulatory inspections as needed.
• Other duties and responsibilities as assigned.

Senior Manager, Clinical Quality Assurance

• Strategic positioning of QINLOCK and ROMVIMZA
• Building and maintaining relationships with stakeholders
• Analyzing market and competitor dynamics
• Planning and executing regional events

Senior Manager, GMP Quality Assurance

Manager, Regulatory Affairs

Oncology Territory Manager

Oncology Territory Manager

Senior Manager, Clinical Quality Assurance

Key Account Manager, Oncology