SomaLogic Senior Manager, Quality Assurance 2018-112 in Boulder, Colorado

SomaLogic is an EEO/AA employer(Minorities/Females/Disability/Veterans) committed to a diverse workforce. SomaLogic is a 200-person privately owned biotechnology company thatdelivers precise and personalized health insights using its proprietarytechnology, which measures changes in thousands of different proteins inblood and other sample types. We are a dedicated team of science-basedcolleagues working to maximize health and wellness for people around theworld. We are seeking a strong Quality leader with the expertise and knowledgeto help in meeting our company goals and objectives. This position will be key for implementation and maintenance of a qualitysystem that addresses multiple market types in the US and internationally. Thequality team supports a broad range of different markets and regulatoryrequirements, from IVD (US and International) to CLIA testing and LabDeveloped Tests (LDT) and other markets for health and wellness insights.This individual will be a leading member in the company s overall complianceefforts and may be asked to address new and developing compliancerequirements. This position will be responsible for overseeing qualityprocesses that support product development to production. Key Job Responsibilities: * Supervises members of the Quality Department. * Works directly with various functional areas to provide processanalyses oversight on a continuing basis to enforce requirements and meetguidelines. * Provides expertise and guidance in interpreting policies,regulatory and/or governmental regulations, and agency guidelines toassure compliance in conjunction with Regulatory Affairs. * Leads audit and inspection preparation; leads resolution of auditand inspection findings; and liaises with auditing groups, inspectors andinternal technical experts through all stages of the audits. * Oversees quality activities in support of ISO compliance, CLIAcompliance, and other standards. * Provides alternative methods and procedures in solving problems andmeeting diverse markets needs. * Visits and confers with representatives of material and componentvendors to obtain information related to supply quality and vendor qualitystandards. * Confers with technical staff about quality assurance of newproducts designed and manufactured products to ensure quality by design. * Ensures the quality assurance programs and policies are maintainedand modified regularly, as needed. * Provides Quality Systems training to new hires and on-going QualitySystems training as needed. * Oversees and actively participates in major quality processes likeCAPA, Nonconformances, Complaints, Vendor Assessments, etc. * Facilitates application of uniform standards and enables bestpractice sharing worldwide in support of company's global mission. Education Degree in Scientific/Technical field (i.e. Chemistry, Biology,Biochemistry, Molecular Biology, or related field) * PhD with 8+ years relevant experience, or * Master s degree with 20+ years of relevant experience, or * Bachelor s degree with 22+ years of relevant experience Skills and experience * Experience with 21 CFR Part 820, including Part 11, andISO13485 quality system requirements. * Experience in the development, qualification, and validation ofsoftware is a plus. * Demonstrated skills in resolving issues in a highly diplomatic andtactful manner. * Experience with CLIA regulations and compliance is desired. * Demonstrated ability to work effectively in a fast paced,cross-functional team-oriented environment through excellent verbal andwritten skills and ability to negotiate. * Strong problem-solving skills and demonstrated ability to achievecontinuous improvement. Work Environment: Work is in typical office environment but may require occasional work in atypical laboratory environment with personal protective equipment userequired. This position may require up to 15% travel. Some of the travel maybe international.Apply Here: http://www.Click2Appl