Astellas Pharma Senior Specialist, Quality Systems & Compliance in South San Francisco, California
We are seeking a highly motivated Senior Specialist, Quality Systems & Compliance, reporting to the Associate Director, Quality Systems & Compliance, who will provide input and oversight to ensure all manufacturing quality system requirements are effectively established and maintained; report on the performance of the quality system to senior levels of management with responsibility for review; and identify opportunities to proactively assure compliance to all applicable internal requirements, as well as domestic and international quality regulations. The Specialist/Senior Specialist, Quality Systems & Compliance, will be tasked to perform a wide variety of activities to ensure that Astellas Gene Therapies’ Quality requirements are being fulfilled through effective performance monitoring; to ensure that performance and quality of products conform to established standards and agency guidelines; and to identify and implement solutions for issues / gaps discovered to prepare for commercialization.
This position will be located in South San Francisco.
Establish and maintain expert knowledge on quality systems/regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 600, 211), EudraLex and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization, continuously review guidance publications for industry and upcoming changes to regulations.
Effectively communicate changes in regulatory / compliance requirements to functional groups ensuring understanding and implementation of required actions, and overall compliance.
Facilitate cross functional team discussions in support of major/critical deviation investigations and change controls and draft risk assessment report documents as per defined timelines.
Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs to create efficiencies in practices.
Effectively drives for results and effectively network and communicate cross-functionally, cross-site.
Drives continuous improvement of the AGT QMS through new QMR content that includes communication and escalation of Quality System health.
Supports continuous improvement and drives compliance through gap assessments and compliance changes to stay aligned with regulatory guidelines.
Will lead the execution, maintenance, and periodic review of Quality Agreements with external suppliers/vendors.
Provides QA oversight throughout the lifecycle of the Vendor Change Notification (VCN) process and ensures timely completion execution/management of related Change Controls prior to the vendor change being made.
Supports increased inspection readiness activities such GMP/Compliance Walkthroughs.
Executes internal audits in support of improving site compliance and inspection readiness.
Executes supplier audits and implements Astellas requirements where applicable.
Prepares and completes audit reports and communicate results internally to other groups.
Conduct reviews of and maintains the Approved Supplier List in support of the external supplier lifecycle.
Supports the preparation, execution, and follow up activities related to and Pre-Approval and regulatory inspections including compiling / reviewing documents, policies and procedures to ensure audit readiness, including inspection readiness training, management of mock inspections, and management of inspection logistics.
Prepare metrics and provide updates related to supplier quality, audits, and general site compliance
Perform other support responsibilities as requested to support Quality and Regulatory oversight activities
Specialist : BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with typically 7+ years relevant experience or typically 4+ years with Master’s degree
Senior Specialist : BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with typically 10+ years relevant experience or typically 8+ years with Master’s degree
Current and working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing training and document management requirements
Proven ability to manage multiple projects while maintaining quality
Successful history of working independently with minimal supervision
Strong interpersonal skills with reputation for collaboration with colleagues
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
Travel internationally and domestically up to 15%, as required
Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
Experience with internal or external auditing
Experience with rare/orphan diseases and/or gene therapy products
Experience in startup environment
Knowledge of existing and emerging regulations, standards, or guidance documents related to AAV gene therapy production
- $94,000 - $126,000 (NOTE: Final salary could be more or less, based on experience)
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Product QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans