- Perform batch record review and lot disposition activities for DP and Device Assemblies (e.g., Autoinjectors and Filled Syringe Safety Devices)
- Review analytical data packages associated with DP and Device Assemblies with respect to release and stability testing; must be able to recognize and communicate trends associated with the data over time
- Provide quality oversight for contracted manufacturing and testing activities and input [e.g., troubleshooting, failure analysis, problem solving, and risk management (assessment and mitigation)] for quality events / issues
- Review and approve documentation in partnership with external / internal business partners
- Develop solutions and resolve a variety of moderately complex quality events / issues (e.g., Deviations, Investigations, Out-of-Specification / Out-of-Trend investigations)
- Review and approve technical reports supporting contracted manufacturing and testing activities as well as analytical method validation protocols / reports
- Perform internal audits of in-house cGMP operations and external audits of Ionis' vendors, Contract Manufacturing Organizations and Testing Laboratories (i.e., CMOs and CTLs), as assigned
- Support the conduct of domestic and international regulatory authority inspections, as well as partner cGMP audits of Ionis Pharmaceuticals, as needed
- Develop, implement and deploy enhancements to Ionis' Quality System policies and procedures, and support company continuous improvement programs
- Bachelor's Degree or post-secondary education in a relevant discipline (e.g., chemistry, biological sciences, etc.) preferred with a broad knowledge of drug development and at least eight (8) years of industry experience
- At least five (5) years Quality Assurance related experience in a cGMP environment with a proven track record in batch documentation and quality control data review (with strong attention-to-detail), and lot disposition activities including handling / managing / resolving quality events and issues
- Knowledge of FDA, EMA, Health Canada, MHLW, ICH, and ISO regulatory expectations and requirements and other guidelines related to cGMP activities (knowledge of Design Control and Device regulatory requirements and combination product development and commercialization is a plus)
- Experience reviewing technical and validation protocols, records and reports
- Experience performing internal and external audits against domestic and international regulatory requirements and industry expectations as related to cGMP activities
- Customer oriented with excellent communication skills and the ability to apply pragmatic logic to problem solving and issue resolution
- Effective communicator (verbal and writing skills)
- Solid interpersonal and teamwork skills
- Exhibits integrity in words and actions
- Ability to adjust to and manage change
- Outstanding organizational and time-management skills with ability to multitask and prioritize
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Senior Manager, Quality Assurance - Carlsbad, United States - Ionis Pharmaceuticals Inc
Description
Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.
Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises.Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis' platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.
We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees.We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team.
While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive.
We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation.
From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees.
These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow.
Join us and experience our unique culture while you develop and expand your career.SENIOR MANAGER, QUALITY ASSURANCE / COMPLIANCE (QA/C) - BATCH RELEASE
We are seeking an experienced QA professional to join our QA/C group at the Senior Manager level to perform key batch record review and disposition tasks supporting Ionis clinical products.
This individual's primary responsibility will be to assure the compliance and quality for contracted manufacturing and testing activities for Drug Products (DP) and Device Assemblies with respect to applicable domestic and international regulatory expectations and requirements, and industry guidelines (as related to cGMP), and Ionis' Quality Management System and Standard Operating Procedures (SOPs).
The successful candidate will function as an individual contributor and report to the Associate Director, QA/C.PRIMARY RESPONSIBILITIES:
REQUIREMENTS:
COMPETENCIES IDENTIFIED FOR SUCCESS:
Ionis offers an excellent benefits package Follow this link for more details: Ionis Benefits
Full Benefits Link:
,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $75,260 to $113,785
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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