Research and Development Quality Assurance Manager (6010)

Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA. DescriptionThe QA Manager assists in the development and implementation of R&D Quality Assurance activities for Cubist. Responsible for assuring the adequacy of company non-clinical and clinical systems through internal and external auditing, involvement in systems development, and training of personnel. Serves as a lead resource to R&D project subteams.Duties and Responsibilities• Serve as primary contact for Cubist development teams to provide expert GCP/GLP and general QA support; act as liaison between product development teams and QA. • Oversee and/or perform audits of non clinical and clinical research sites, systems and processes to ensure compliance with current Good Clinical Practices, ICH guidelines and Good Laboratory Practices.• Investigator Site Audits • System / Process Audits• Vendor audits (CROs, Labs) • Data Audits• Trial Master File Audits • Document Audits• Develop and maintain audit plans and schedules in line with organizational goals and objectives (aligned with audit strategy).• Evaluate significance of audit findings and coordinate timely responses and implementation of corrective actions.• Analyze audit findings and prepare and present results to management.• Oversee selection and work of contract auditors to ensure they are properly qualified, trained in Cubist procedures, and work products meet Cubist standards.• Review clinical documents including protocols, amendments, sample Case Report Forms, and sample/master Informed Consent Forms for adequacy and compliance, as required.• Support effort in preparing for and hosting FDA and other regulatory agency inspections.• Participate in the continued development and monitoring of Cubist’s internal quality systems; Write SOPs, as assigned.• Participate in the development and execution of internal training programs; Prepare and deliver GCP related training at investigator’s meetings, as required.• Keep abreast of changes in regulations and enforcement action and make recommendations for changes to Cubist policies and practices as needed.• Train and mentor staff, as assigned.Required SkillsBehavioral Attributes• Leadership and interpersonal skills; ability to interact with all levels of management• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner• Mature, problem solving attitude; exhibits judgment and a realistic understanding of the issues; able to use reason even when dealing with emotional topics• Ability to develop positive interpersonal relationships• Detail orientation; highly organized; self starterRequired ExperienceEducation/Certification Bachelor of Science or related degree, advanced degree preferred.Experience5-8 years of pharmaceutical industry experience in an area regulated by GCP and GLP regulations with at least 2 years in a Quality Assurance role with direct auditing experience.C. Knowledge, Skills, and Abilities Strong verbal, written, communication, and organizational skills are required. Candidate possesses dynamic interpersonal and teamwork skills. Individual should be willing to travel domestically and internationally (up to 40%).Technical Skills• Strong working knowledge of GCP regulations, ICH guidelines and EU Directive for Clinical Trials• Good understanding of 21CFR Part 11 with respect to clinical processes and systems. Familiar with government compliance programs, HIPAA and Subject Data Protection regulations and laws.• Working knowledge of drug development process and clinical trial operations• Excellent communication, organizational, interpersonal and computer skills• Strong process orientation; ability to develop clear and concise procedures and related documentation• Proven ability to work on multiple projects simultaneously and set priorities.• Proficiency in a Windows environment (Microsoft Word, Excel, Project, Visio, Powerpoint, Outlook).Total Rewards:

Our outstanding total rewards package includes: competitive base salary; annual incentive plan with payouts based on results; company-wide performance based equity program; choice of medical plan; dental, life and disability insurance; employee assistance program; flexible spending accounts; 100% vesting in our 401K plan with a competitive company match; employee stock purchase plan; tuition reimbursement; 12 paid holidays, 4 of which are floating; 3 weeks vacation; flexible work schedules; comprehensive reward and recognition program.

Application instructions:

We encourage you to apply to Cubist by applying directly at:
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Submitting a resume online at a job site could cause valuable screening information to be missed. We are an Equal Opportunity Employer.

Note to Recruiters:

Relationships with professional recruiters are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors. We are also interested in establishing new relationships with experienced life science recruiters. In order to recruit on Cubist’s behalf, each recruiting firm needs to have a written contract in place and agree to present candidates directly to Human Resources.