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 Quality Assurance professional 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? External Audit
- Lead and/or support the development of supplier audit program, including planning, execution, risk mitigation and close out of planned external audits or assessments, including working with and coordinating contracted auditors and audit records.
- Liaise with Supplier Quality Program stakeholders to coordinate and prioritize the completion of external audits
- Communicate with and monitor external supplier compliance to audits, quality agreements, and corrective actions
- Monitor, update and report on external audit program metrics
Internal Audit (self-inspection)
- Manage and execute the internal audit strategy and schedule with cross-functional team, including Quality and Site leadership
- Lead and/or coordinate the planning, execution, risk mitigation and close out of internal audits
- Collaborate with and coach internal auditees and Quality partners for internal audit observations; ensure auditees deliver appropriate CAPAs and monitor through to closure.
- Ensure that audit results are timely, constructively written, and formally recorded and reported with corrective and preventive actions documented appropriately.
- Monitor, update and report on internal audit program metrics
- Train, coach and develop co-auditors and subject matter experts to support the audit program
Additionally, May be responsible for:
- Support hosting client audits and regulatory health authority inspections
- Compile and provide operational and quality metrics for periodic Management review.
- Promote a Quality Culture by driving continuous improvement, innovation, teamwork and efficiency.
- Perform Quality systems element assessments/audits to identify deficiencies in processes and procedures according to client quality and regulatory standards and guidance
- Establish core quality programs, oversight and controls for Document Management, Change Management, Deviation/Investigation Management, and Training Management
- 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
- 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
- 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
- Preferred certifications: ASQ, ISO standards for auditing including 13485, ISO 9001, ISO 14971
- 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.