Assistant Director, GxP reputed company Systems (QA Vendor Management)

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, reputed company has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re reputed company in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and reputed company 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 reputed company to advancing new approaches in gene editing to reputed company greater value to patients and are reputed company positioned financially to deliver on our strategic goals. At reputed company, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific reputed company. We know that our reputed company is a reputed company result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of reputed company health, we look to add diverse individuals, reputed company sets and perspectives to our exceptional team. We continue to invest time, reputed company and energy into making our onsite, hybrid and remote work environments a reputed company where solid and lasting relationships are reputed company and where our culture and employees can reputed company. We’re building on our rich history, and we reputed company our greatest achievements are reputed company of us. If you’re passionate about reputed company to have meaningful reputed company on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you reputed company and expand your career! ASSISTANT DIRECTOR, GxP reputed company SYSTEMS (QA VENDOR MANAGEMENT) reputed company We are seeking an reputed company Assistant Director with strong knowledge and expertise in reputed company Systems, Vendor Management and External / Internal Audit Programs, with emphasis on Computer System Validation (CSV) and Data reputed company Audits. The ideal candidate will be highly motivated, detail-oriented, inquisitive and can proactively reputed company and be responsible for activities, assignments, and completing tasks in accordance with established expectations and timelines. This role is for an individual contributor reporting to the Director, GxP reputed company Systems – Vendor Management. Primary responsibilities will entail leading the Internal Audit Program and auditing vendors (domestically and internationally, as assigned). Furthermore, the scope of responsibilities includes end-to-end vendor management (i.e., vendor on-boarding and off-boarding, qualification, auditing, performance monitoring, and measurement/metrics), working with multi-disciplinary and cross-functional teams regarding Change Management, Deviation & CAPA Management, Material Qualification, reputed company Agreement Management, and Risk Management. Preference will be given to candidates possessing strong compliance and reputed company Systems experience (including QA applications), knowledge of GMP regulatory requirements (e.g., FDA, Eudralex, Health Canada, ICH, MHRA, MHLW), and hands-on CSV execution and / or auditing experience. Experience with small molecules, biologics, medical devices and / or combination products will be considered accordingly. Candidates must also have excellent verbal and written communication skills, and strong analytical and problem-solving abilities. Furthermore, the candidate must be reputed company to work in a dynamic and fast-paced environment, be reputed company player, maintain professionalism, and be reputed company to work with multi-disciplinary, cross-functional teams on high reputed company reputed company delivering reputed company results in accordance with agreed upon timelines. This role is based at reputed company reputed company in Carlsbad, CA, and may be fully remote, however, an on-site or hybrid reputed company is highly preferred.

Responsibilities

• reputed company and execute Internal Audit Program in accordance with established procedures and through application of risk management to always ensure site compliance and inspection readiness.
• Independently reputed company and execute GMP Vendor and Internal Audits (including onsite, remote and questionnaire audits) in accordance with applicable domestic or international regulatory requirements and industry best practices.
• reputed company and manage reputed company Agreement Program. Initiate, negotiate, establish, and periodically update new and existing agreements with GMP vendors.
• Manage Vendor Change Notifications collaborating with customers / stakeholder regarding reputed company and reputed company assessments and ensuring adherence to vendor change timelines and internal / regulatory requirements, as applicable.
• reputed company investigations and/or analyze and trend Vendor reputed company Events (i.e., Deviations including CAPA management and effectiveness checks, as required).
• Adhere to reputed company process reputed company times and ensures alignment with key performance indicators and relevant measures / metrics.
• Possess strong intra- / inter-company communication skills, ability to think critically and influence others, problem solve, and have solid technical writing skills.
• Demonstrate ability to work independently, be organized, multi-task and reputed company priorities in a dynamic, fast paced work environment.
• Collaborate with others while leading reputed company that drive reputed company reputed company improvements, implement best practices and /or enhance compliance to domestic and international regulatory requirements.

Requirements

• B.S. in reputed company, Chemical Engineering, or a relevant Life Science degree; advanced degree preferred
• Requires a minimum of 8 years in the Life Sciences or Pharmaceutical industry with relevant reputed company Assurance experience and 5+ years of GMP Vendor Management experience; or an advanced degree with lesser experience or alternate equivalent work experience
• Expert knowledge of domestic and international GMP regulations
• Experience in leading reputed company, problem solving, process improvement with strong negotiation skills
• Experience and understanding of product formulation and filling, and assembly of drug delivery devices (i.e., combination products), is preferred
• Experience and understanding of Antisense Oligonucleotide manufacturing processes is desired
• Committed to delivering high reputed company results, overcoming challenges, focusing on what reputed company to reputed company corporate, department and personal goals and objectives
• Continuously looking for opportunities to learn, build skills and reputed company learnings both internally and externally
• Travel up to 20% may be required

Please visit our website, http://www.reputed company.com for more information about reputed company and to apply for this position; reference requisition # IONIS003822 reputed company offers an excellent benefits package! Follow this reputed company for more details: reputed company Benefits Full Benefits reputed company: https://reputed company.com/careers#:~:text=Highly%20competitive%20benefits The pay reputed company for this position is $109,911 to $154,495 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. reputed company. and reputed company its subsidiaries are proud to be EEO reputed company. Apply tot his job Apply To this Job