Director, Quality Assurance - GMP Vendor Management
Apply NowCompany: Ionis
Location: Carlsbad, CA 92009
Description:
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, QUALITY ASSURANCE - GMP VENDOR MANAGEMENT
SUMMARY:
This position will lead the GMP Vendor Management Program at Ionis Pharmaceuticals, including leading vendor audits, qualification, and requalification schedule. This high impact position reports to the Head of GMP Quality.
This person is responsible for the oversight of all Quality aspects performed at manufacturing and testing partners of Ionis's clinical and commercial products in the following modalities and unit operations: Pharmaceuticals, Oligonucleotides, Devices, Combination Products, RSMs, Drug Substance, API, Drug Product, Aseptic Fill Finish Operations, Device Assembly and Packaging. This person may also lead and/or support continuous improvement initiatives related to Ionis's QMS and procedures for CMO and partner oversight.
The position requires an experienced QA professional with strong expertise in GMP Audits and Vendor Qualification. Auditees include a variety of GMP service providers including Contract Manufacturing Organizations (CMO), Contract testing laboratories, Critical raw materials providers, shipping and warehousing vendors, and software vendors among others. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required. Since Ionis finished products come under combination drug products regulations, expertise with device vendors as well as design control oversight is desirable.
The incumbent would develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.
RESPONSIBILITIES:
CORE COMPETENCIES:
REQUIREMENTS:
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003691
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 $104,764 to $145,330
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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, QUALITY ASSURANCE - GMP VENDOR MANAGEMENT
SUMMARY:
This position will lead the GMP Vendor Management Program at Ionis Pharmaceuticals, including leading vendor audits, qualification, and requalification schedule. This high impact position reports to the Head of GMP Quality.
This person is responsible for the oversight of all Quality aspects performed at manufacturing and testing partners of Ionis's clinical and commercial products in the following modalities and unit operations: Pharmaceuticals, Oligonucleotides, Devices, Combination Products, RSMs, Drug Substance, API, Drug Product, Aseptic Fill Finish Operations, Device Assembly and Packaging. This person may also lead and/or support continuous improvement initiatives related to Ionis's QMS and procedures for CMO and partner oversight.
The position requires an experienced QA professional with strong expertise in GMP Audits and Vendor Qualification. Auditees include a variety of GMP service providers including Contract Manufacturing Organizations (CMO), Contract testing laboratories, Critical raw materials providers, shipping and warehousing vendors, and software vendors among others. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required. Since Ionis finished products come under combination drug products regulations, expertise with device vendors as well as design control oversight is desirable.
The incumbent would develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.
RESPONSIBILITIES:
- Enhance/Upgrade Vendor Management Program by authoring/revising QA procedures
- Develop internal and external audit schedules and execute per audit plan
- Applying Risk Management principles to qualification and oversight of external service providers
- Assist in drafting, negotiating and maintenance of Quality Agreements with CMO's
- Present and defend the GMP Vendor Management Program in regulatory inspections and management review
- Works closely with functional areas to periodically provide applicable vendor performance and quality metrics
- Maintain current knowledge of Regulatory concerns on vendor management
- Implement design control requirements as per internal procedures
- Coordinate design review meetings with key stakeholders
- Coordinate Review and assembly of Design History Files
CORE COMPETENCIES:
- Expertise in applying GMP regulations to API and drug product manufacturing and analytics including areas listed below:
- Pharmaceutical manufacturing and Quality Assurance
- Discrepancy Management (deviation investigations, CAPA development, Change Control)
- Planning and conducting audits, authoring audit reports, and follow up on CAPA implementation
- Risk Assessment to guide level of QA audits and oversight
- Strong critical thinking, problem solving, influencing, and intra-/ inter-company communication skills
- Multi-task and adjust priorities in a dynamic environment
REQUIREMENTS:
- B.S. in Chemistry, Chemical Engineering, or related disciplines; advance degree preferred.
- At least 15 years of experience in GMP manufacturing with minimum of ten years in a QA auditing role
- Strong knowledge of FDA, EMA, ICH regulations and guidelines on vendor management program
- FDA QSR 21 CFR Parts 4 and 820 / ISO 13485, ISO 14971, and Regulation (EU) 2017/745).
- Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
- Experience in presenting and defending Vendor Management program during regulatory inspections
- Experience in problem solving, process improvement, negotiations, and supervision
- Experience in Risk Management and Commercial QA operations is highly desired
- Experience and understanding of drug delivery devices and manufacturing processes is desirable
- Design Control compliance experience working with clinical and medical groups is desirable
- May require up to 20% travel to CMOs upon lifting of travel restrictions
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003691
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 $104,764 to $145,330
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.