Staff Quality Specialist

Company Description

Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

For more information, visit www.sequoiabiotech.com/.

What will you be doing?

Seeking a seasoned, multi-disciplined Staff Quality Assurance Specialist with experience in managing, administering developing, and delivering quality programs and oversight with various therapeutic products within the life sciences industry. This consultant will support and partner with our pharmaceutical, biopharmaceutical, diagnostics, and medical device/combination clients leading quality systems design and development, establishing processes and procedures, and quality operational activities.
Is this job for you?

• Perform Quality systems element assessments/audits to identify deficiencies in processes and procedures according to client quality and regulatory standards and guidance
• Develop and establish quality systems programs and elements in processes and procedures, instructions, and other documentation, as well as, assisting clients with continuous process improvements
• Establish core quality programs, oversight and controls for Document Management, Change Management, Deviation/Investigation Management, and Training Management
• Provide Quality operational expertise and development/oversight for our clients both internally and externally for Quality oversight and controls, in-process quality manufacturing, supply chain, supplier/vendor, and CDMO activities
• Provide expert technical and operational support for resolving quality deficiencies and remediation activities
• Prepare clients for audit readiness, risk management and mitigation, and review of quality procedures, documentation, and records
• Perform risk assessment for cGMP compliance and functional risk programs
• Lead and provide Quality review, certification and management of batch records and work orders to ensure compliance with SOPs and cGMPs for lot release and disposition
• Lead, plan, execute and provide report for audits at suppliers, contract services, and within the internal quality team
• Participate in the development, implementation, and maintenance of the company's quality management systems
• Lead investigations and activities for a variety of non-conformances which may include deviations, CAPA, OOT, AA, or OOS activities
• Gather information/data, prepare investigation reports, and shape corrective/preventive actions to resolve recurring problems with permanent solutions
• Support audit readiness and pre-approval inspection (PAI) readiness of internal and external systems
• Work cross-functionally with various departments to ensure Quality culture and processes align with project objectives and timelines
• Review manufacturing and facility operations records and documentation associated manufacturing of products
• Provide assistance in preparation and during regulatory inspections, due diligence audits, serving as QA escort when needed
• Create, review and maintain quality records/metrics and make process improvement recommendations to management

Who you are?

• Bachelor's degree within a life science or related field required
• 8-13 years of experience within Pharma/Biopharma, Medical Device, or Diagnostics industry
• AQS certification preferred
• Extensive experience working with and leading Quality for various products in support of clinical/commercial manufacturing
• Experience in the application of Quality Assurance principles, concepts, industry practices, and standards
• Knowledge of cGMP standards, FDA regulations, US standards 21CFR210, 21CFR211, 21CFR11, 21CFR820, ICH Quality Guidelines, Quality System Regulations and ISO standards including 13485, ISO 9001, ISO 14971
• Significant experience with a variety of software including MS Office; Project, Visio, LIMS, and EDMS
• Excellent communication and leadership skills as well as a strong work ethic

We Provide a comprehensive Total Rewards Program not limited to:

• Excellent healthcare options: Medical, vision, prescription & dental

• Family Focus & Balance: Parental leave, flexible time-off and Employee Assistance Program

• Financial Security: 401(k) with employer matching

• Tuition Reimbursement: Continuing education for every season of your career

• Employee Recognition Programs

Compensation

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $106,991.88/year in our lowest geographic market up to $ 152,382.37/year in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

Legal Statement
Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.