Director/ Executive Director, Development Quality Assurance

Scorpion Therapeutics; United States; Remote; USD 181,000 - 283,000; Full time

Job summary

A leading biotechnology company is seeking a Director/Executive Director for Development Quality Assurance. This role involves providing leadership for health authority inspections and ensuring compliance with GCP/GVP/GLP standards. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical industry and a strong track record of managing regulatory inspections. Join a dynamic team focused on innovation and patient impact.

Benefits

Excellent benefits package

Qualifications

• Minimum 10 years of relevant GCP and/or GVP quality assurance experience.
• Demonstrated track record of leading health authority inspections.
• Expert knowledge of the drug development process and GxP requirements.

Responsibilities

• Lead preparation and management of global regulatory agency inspections.
• Oversee training for defined SMEs and ensure setup of pre-inspection meetings.
• Collaborate with functional areas to enhance inspection readiness.

Skills

Leadership

Communication

Organizational Skills

Attention to Detail

Education

Bachelor and/or Masters degree in healthcare and/or scientific-related discipline

Job description

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Headquartered in Carlsbad, California

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

Position: DIRECTOR/EXECUTIVE DIRECTOR, DEVELOPMENT QUALITY ASSURANCE

Summary

We are seeking a highly motivated individual to join as a Director/Executive Director, Development Quality Assurance. This position will provide leadership and strategic oversight for all GCP/GVP/GLP health authority inspections and drive QA operational activities.

Responsibilities

Health Authority (HA) Inspection Planning, Preparation, Management, and Follow-up

• Lead the preparation for and management of global regulatory agency inspections (end to end), including but not limited to for sponsor/MAH, vendor/partner, and/or investigator site inspections, working in tandem with the assigned QA lead and Development QA management, as applicable:
• Coordinate all HA inspection planning requests (e.g., list of clinical trials) with relevant functions
• Coordinate all inspection preparation activities, including pre-inspection dossiers and coordination/conduct of pre-inspection visits, as applicable
• Act as inspection host and/or other key role (i.e., backroom lead) during conduct of inspection
• Lead the assessment of reports and results from HA inspections, including the associated risks and recommendations, for provision to relevant leadership
• Oversee the preparation of final response documents
• Coordinate and provide management review of all HA inspection responses
• Coordinate tracking/management of inspection commitments
• Lead creation/maintenance/enhancement of documents for pre-inspection preparation and inspection tools
• Lead mock inspections and other inspection preparation activities
• Oversee training for defined SMEs and ensure setup of pre-inspection preparation meetings for line unit heads and appropriate staff
• Lead/collaborate with other Development QA team members to complete inspection follow-up activities within and outside the department, as needed
• Oversee tracking of QA-managed Health Authority inspection data
• Present risks and mitigations, as well as lessons learned, to broad audiences, including senior leadership and at Quality Management Review meetings
• Manage and/or mentor staff on the conduct of pre-inspection visits and/or other inspection-related activities

Quality Operations and Other (GCP/GVP/GLP)

• Closely collaborate with relevant functional areas to enhance inspection readiness framework across the organization with a focus on proactive quality
• Lead priority vendor/CRO and/or corporate partner QA-QA relationships
• Lead/support QMS initiatives
• Identify, develop, and report metrics for management review that will form the basis for continuous improvement practices and processes
• Draft and/or review procedural documents to assess their adherence to applicable regulatory standards and corporate goals
• Define, implement, and/or lead Development QA and/or company/cross functional yearly goals and initiatives as assigned
• Stay current with new or revised regulations and other regulatory intelligence and assess impact

Commensurate With Experience/Level

Manage Development Quality Operations (GCP/GVP/GLP) team, which is responsible for:

• Audit strategy/planning/resourcing
• Vendor management
• Generation of metrics and tracking/trending, including deviations/CAPAs
• Quality systems
• Process improvements

Requirements

• Bachelor and/or Masters degree (healthcare and/or scientific-related discipline is highly desirable)
• Minimum 10 years of relevant GCP and/or GVP quality assurance experience in the pharmaceutical or biotechnology industry with a minimum of 8 years in GCP; GLP experience a plus
• Demonstrated track record of leading health authority inspections (e.g., FDA, EMA, MHRA, Health Canada) of all types (e.g., sponsor/MAH, vendor, investigator site), including strong track record of hosting inspections and mock inspection readiness planning and execution
• Expert knowledge of the drug development process and GxP requirements (i.e., clinical studies, post-marketing/pharmacovigilance, and laboratories)
• Extensive global GCP, GVP, and/or GLP auditing experience desired
• Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement
• Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma GxP environment.
• Hands on experience leading cross-functional process improvement initiatives with measurable outcomes.
• Track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
• Strong leadership presence and influencing skills
• Strong interpersonal, verbal, and written communication skills
• Strong organizational and time management skills
• Demonstrates attention to detail and high quality while meeting deadlines and commitments
• Team player and flexible; thrives in matrixed environment
• Strong coaching skills to mentor/develop staff
• Ability to travel up to ~25% (domestic and international), sometimes on short notice

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003697

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

The pay scale for this position is $181,153 to $282,340

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.