About this role
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 SystemImplements, prepares, and presents training programs as required to satisfy regulatory requirementsApplies industry experience to establish and implement best laboratory practices and quality system standards as related to compliancePerforms QA review and approvals as requiredMaintains current records for required certifications and/or accreditationsCommunicates with client and agency auditors, responds to findings, and effectively addresses concerns or findingsProvides information for monthly/quarterly reports to senior site managementIdentifies, implements, and assures adherence to effective quality control measuresMentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the companyLeads complex projects through to completionCommunicates effectively with client staff membersPerforms other duties as assigned Authorization to work in the United States indefinitely without restriction or sponsorshipBachelor’s or Master’s degree in science field from a four year college/university or equivalent education and job experienceAt least five years of medical device (preferred) /biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirementsSolid understanding of chemistry/lab practices.Knowledge of auditing techniquesSelf-confidence, leadership, ability to reason, make sound decisions, and delegateEmpathy and sensitivity towards othersMotivation to excel and inspire excellence in othersAbility to manage the work of others and see projects through to completionStrong communication including verbal, writing, and presentation skillsAbility to communicate effectively and relate well to peopleMental and emotional stability and maturityAbility to handle personal stress and diffuse stress in othersStrong organizational skills and ability to handle multiple prioritiesSets positive example for othersDedication to quality, ethics, and customer servicePride in appearance, conduct, and companyAbility to work effectively under pressure to meet deadlinesGood negotiation and reasoning skillsExcellent written and verbal communications skillsGood judgment and tact recognizing and solving problemsRecognized as understanding, interpreting, and following company policy 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 insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.