BroomfieldRecruiter Since 2001
the smart solution for Broomfield jobs

Senior Compliance Auditor

Company: Bristol Myers Squibb Company
Location: Broomfield
Posted on: June 12, 2019

Job Description:

Description of the area: Global Quality (GQ) - Clinical Trials and Safety, GQ-CT&S is responsible for auditing all processes related to clinical research includingspecific medical affairs processes, and pharmacovigilance activities, to assess compliancewith relevant regulations and applicable policies and procedures. This includesinvestigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. Our department is alsoresponsible for management of regulatory agency inspections and for providing advice on regulatory (GCP and GVP) requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified. Purpose/Objective of the job Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described. Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, includingGlobal Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel,monitoring the status of the project(s) to plan audits and assuring R&D Quality - CT&S leadership as informed. Key Responsibilities and Major Duties Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internalsystems and clinical study reports to assess regulatory compliance; Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewingdocuments, records and data; Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findingsand conclusions; Assess those factors that may affect the reliability of the audit findings and conclusions; Prepare clearly-written, concise, accurate and evidence-based audit report; Review and assess (or support the review) received corrective and preventive action plans according to specifiedtimelines to ensure resolution of audit findings and prevent recurrence. Maintain an in-depth knowledge of governmental regulations impacting clinical researchand PV and development of medicines. Provide advice and counsel concerning GCP regulatory requirements. Collaborate with management in creating and/or reviewing metrics and trend analyses on audits/inspection findings and related CAPAs, for escalation to management and stakeholder Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy. Regularly evaluate clinical research processes to determine compliance withregulatory requirements and established standard operating procedures. May provide mentoring for new staff, as needed. Regular collaboration/contact with GCO and GRSB personnelrelated to projects for which the incumbent is Project Coordinator. Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of healthauthority inspections either at clinical sites or at BMS facilities. Miscellaneous contacts as assigned by R&D quality -CT&S management. Supervisory Responsibility None Key Stakeholders/Contacts - Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located globally; Contact with appropriate technical, supervisory and management personnel internallyand externally (investigator sites, vendors, etc.) in the conduct and reporting of audits. List of minimum requirements Degree/Certification/Licensure Bachelor's degree required - Life Sciences degree preferred Experience/Responsibility and minimum of years: Solid previous experience in clinical trial related roles Demonstrated specifictechnical knowledge of the GCP areas subject to audit, as evidenced by atIeast 4 years in the pharmaceutical industrypreferably in the R&D/clinical trial or equivalent area. Desired minimum 2 years of auditing (GCP auditing is preferred) Competencies/Knowledge/skills Strong skill in risk based prioritization Strong critical thinking to analyze complexsituations and discern critical issues andnon-compliant situations and torecommend appropriate corrective and preventive actions; Good understanding of the drugdevelopment process Demonstrates computer literacy and is ableto function independently within an environment that relied heavily on technology for information and communication Excellent oral and written communication; Fluent in English (and other languages, asapplicable to assigned audit region); Sense of diplomacy and discretion; Maintains the confidentiality and securityof information, data and records; Demonstrates commitment to deliveringhigh-quality work product; Knowledge of governmental regulations impacting clinical research and drug development Understand the appropriateness andconsequences of using sampling techniques for auditing; Ability to make ethical, scientifically soundrecommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindednessand adaptability to a rapidly changing environment; Develops strong working relationships withkey stakeholders; Ability to manage competing priorities. BMS Behaviors and Working conditions : BMS Biopharma Behaviors required : Passion, Accountability, Innovation,Speed Travel Required (nature and frequency) approximately 25% travel to perform auditsand attend professional meetings andseminars. Overnight Absences Required (pertypical month): Approximately 5 days per month Software that must be usedindependently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc )

Keywords: Bristol Myers Squibb Company, Broomfield , Senior Compliance Auditor, Other , Broomfield, Colorado

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Owner Operator CDL-A Oilfield
Description: Built by Truckers for Truckers br Owner Operator CDL-A Oilfield br br Owner Operators hauling frac sand in bulk pneumatics across Wyoming and br the Rocky Mountains. We are maxing out our company (more...)
Company: brady trucking
Location: Cheyenne
Posted on: 06/19/2019

Work at Home Bilingual Customer Retention Expert (English / Spanish)
Description: This position is with Mommy Jobs Online, so please visit mommyjobsonline.com to apply and get registered on our site directly Helping those in need is a way of life for us, and we are looking for more (more...)
Company: Mommy Jobs Online
Location: Broomfield
Posted on: 06/19/2019

Account Executive
Description: 360 Credit Consulting--is looking to hire an--Account Executive--to join our sales team. We are a fast growing consulting firm in the credit industry, and we are looking for a self-motivated, results-oriented (more...)
Company: 360 Credit Consulting LLC
Location: Broomfield
Posted on: 06/19/2019


Medical Recorder Coder
Description: We are seeking experienced self-motivated Inpatient and Outpatient Medical Records Coders to join one of our dynamic groups of coding professionals. This coding team provides high quality coding support (more...)
Company: Mommyjobsonline
Location: Cheyenne
Posted on: 06/19/2019

At Home Data Entry Specialist / Freelance
Description: Mommy Jobs Online is now seeking Data Entry Specialist to work remotely part or full-time. It's time for a career change with fun flexible work hours Come join our virtual team today Job Overview: You (more...)
Company: Mommy Jobs Online
Location: Broomfield
Posted on: 06/19/2019

Drive with Lyft - No car needed.
Description: What is Lyft br Lyft matches drivers with passengers who request rides through the Lyft smartphone app. Signing up to br be a Lyft driver is the perfect opportunity for you to set your own schedule (more...)
Company: Lyft
Location: Broomfield
Posted on: 06/19/2019

Proofreader
Description: What We Do We are experts in the emerging field of customer experience measurement and improvement. Our solutions help brands make sure they are consistently delighting their customers at all touch-points, (more...)
Company: Mommy Jobs Online
Location: Broomfield
Posted on: 06/19/2019

HR Personnel Assistant
Description: Job Duties: You will need to make outbound calls to jobseekers pertaining to joining our remote work-at-home job board to find employment. You will need to post classified job ads on a daily basis of (more...)
Company: Mommy Jobs Online
Location: Broomfield
Posted on: 06/19/2019

MGR CUSTOMER OPTIMIZATION II
Description: About CenturyLink br br CenturyLink NYSE: CTL is the second largest U.S. communications provider to global enterprise customers. With customers in more than 60 countries and an intense focus on (more...)
Company: CenturyLink
Location: Broomfield
Posted on: 06/19/2019

A Genuine Daytime Job From Home!
Description: TeleReach Corporate is a national telephone-marketing firm engaged exclusively in outbound business to business calls. We offer a unique opportunity with an excellent earning
Company: TeleReach Corporate
Location: Broomfield
Posted on: 06/19/2019

Log In or Create An Account

Get the latest Colorado jobs by following @recnetCO on Twitter!

Broomfield RSS job feeds