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 are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we 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 our success is a direct result of the exceptional talent 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 and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

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

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 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 10-15 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 ~20% (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 #IONIS003507

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

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $180,131 to $281,103.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY. 

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