Job Description

This position is Responsible for leading Quality Assurance Department in accordance with vision, values, and strategic goals of the company. It will involve overseeing and facilitating efficient quality operations, assuring consistent client service, implementing laboratory practices as applicable to current regulatory standards, working with client and agency audits and correspondence, maintaining certifications, Quality Assurance policy development, and maintenance, following up promptly on any quality and compliance related issues, and implementing respective CAPA actions to assure adherence to the required quality metrics. Other responsibilities are as follows:

• Manage QA, QC, Regulatory and Compliance activities to help achieve quality/business goals as outlined in the Quality Manual, Policy and SOPs to assure compliance with all applicable Standards and Regulations from all local, state, federal and international sources.
• Monitor for trends, identify improvements, and assure the effectiveness of the Quality Management System
• Implements, prepares, and presents training programs as required to satisfy regulatory requirements
• Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance
• Performs QA review and approvals as required
• Maintains current records for required certifications and/or accreditations
• Communicates with client and agency auditors, responds to findings, and effectively addresses concerns or findings
• Provides information for monthly/quarterly reports to senior site management
• Identifies, implements, and assures adherence to effective quality control measures
• Mentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the company
• Leads complex projects through to completion
• Communicates effectively with client staff members
• Performs other duties as assigned

Qualifications

• Authorization to work in the United States indefinitely without restriction or sponsorship
• Bachelor’s or Master’s degree in science field from a four year college/university or equivalent education and job experience
• At least five years of medical device (preferred) /biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirements
• Solid understanding of chemistry/lab practices.
• Knowledge of auditing techniques
• Self-confidence, leadership, ability to reason, make sound decisions, and delegate
• Empathy and sensitivity towards others
• Motivation to excel and inspire excellence in others
• Ability to manage the work of others and see projects through to completion
• Strong communication including verbal, writing, and presentation skills
• Ability to communicate effectively and relate well to people
• Mental and emotional stability and maturity
• Ability to handle personal stress and diffuse stress in others
• Strong organizational skills and ability to handle multiple priorities
• Sets positive example for others
• Dedication to quality, ethics, and customer service
• Pride in appearance, conduct, and company
• Ability to work effectively under pressure to meet deadlines
• Good negotiation and reasoning skills
• Excellent written and verbal communications skills
• Good judgment and tact recognizing and solving problems
• Recognized as understanding, interpreting, and following company policy

Additional Information

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of San Jose, CA are encouraged to apply.

Target compensation: $80,000-$100,000/year

Excellent full-time benefits including:

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.