IT Compliance Manager

Pharmacyclics

Sunnyvale , CA 94085

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

Pharmacyclics is seeking for an IT Compliance Manager

General Position Summary/Purpose:

The IT Compliance Manager will be responsible for leading ongoing IT Compliance of IT Systems, Audit Remediation, and SOP authoring initiatives supporting various IT client organization including but not limited to Manufacturing, Quality Control, and R&D business units. The individual will provide support to ensure Change management, CAPA, Deviations, training and SOP and IT systems reviews are conducted in accordance with established policies and procedures. The individual will collect and maintain Quality metrics to support IT controls across the entire IT organization and, to support Regulatory Audits and Inspection Readiness. In addition, the individual will have hands on experience with supporting Internal and External audit exercise. The individual must have hands-on experience in the Biotechnology/Pharmaceutical FDA regulated industry.


Key Accountabilities / Core

Job Responsibilities:
  • Lead in the identification, collection and management of Quality Metrics related to various IT control areas.

  • Provide assistance in the development and maintenance of policies, procedures, and other guidance documents that provide compliance to internal and external IT controls.

  • Work as part of IT compliance to support operational change control process and provide oversight and compliance approvals of project deliverables; IT change requests and IT issue reports.

  • Evaluates deliverables and determines if new IT infrastructure or changes to existing infrastructure can move to production

  • Track and ensure completion of Audit and Inspection related findings are completed on time

  • Assist in the development and maintenance of assessment programs for IT process, people, and procedures.

  • Provide assistance in performing periodic reviews by working with onsite and offshore QA and Compliance resources.

  • Provide assistance conducting IT vendor/supplier audits and adherence to company policies and procedures

  • Provide management oversight for managed services vendor staff working on IT Compliance and operational activities.

Qualifications and Requirements:

  • Bachelor's Degree in Computer Science, Information Technology, or related discipline.

  • 6+ years of pharmaceutical GxP system validation experience.

  • Excellent communication and documentation skills with strong attention to detail and well organized.

  • Strong knowledge of IT Controls and Audit processes and applications Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, and other regulations governing drug development and commercialization.

  • Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP, NIST, ICH Q9)

  • Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause.

  • Demonstrated strong knowledge of FDA audit procedures and IT Quality system validation best practices.

  • Ability to assist in documenting and providing audit response to internal and external audits in a timely fashion

  • Familiarity with SDLC in the FDA regulated Biotechnology/Pharmaceutical industry is necessary.

#LI-SH7

Equal Opportunity Employer Minorities/Women/Veterans/Disabled


See if you are a match!

Upload your resume to see how your resume matches up to this job

Matched to your resume
resumetriaasssdfel.jp… Change
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
(UsaCaSunnyvale) Regulatory Compliance Audit Manag...

Google Inc.

  Posted 2 days ago

VIEW JOBS 4/18/2018 12:00:00 AM 2018-07-17T00:00 Google accountants are a savvy bunch who handle the core accounting responsibilities at Google. As a member of this team, you know your accounting principles and the full accounting process end to end. You'll advise on financial reports required by governmental regulations, and you'll review, analyze, and interpret financial and budgetary reports -- and all this sounds like fun to you. Every day is a new challenge, and you're continually looking for ways to help our team get better at what we do, in the most efficient way possible. A team player at heart, you collaborate with our global team, advocate best practices and roll up your sleeves to pitch in when it's all hands on deck. You move fast while keeping your attention to detail, and you tap into your problem-solving skills to support Google's business objectives. Our mission is to enhance and protect organizational value by providing risk-based and objective assurance, advice, and insight. Internal Audit achieves audit excellence by enabling effective risk management, enhancing and protecting organizational value, and delivering objective and reliable results. You will advise business and engineering groups to identify areas of risk and make valuable recommendations on controls. You will have the opportunity to influence change and decisions for business initiatives including product launches and system implementations. You enjoy working in a dynamic environment, are passionate about technology, and able to focus on key issues and the details that come with it. The name Google came from "googol," a mathematical term for the number 1 followed by 100 zeros. And nobody at Google loves big numbers like the Finance team when providing in depth analysis on all manner of strategic decisions across Google products. From developing forward-thinking analysis to generating management reports to scaling our automated financial processes, the Finance organization is an important partner and advisor to the business. ## Responsibilities * Identify and call attention to compliance and repetitional risks through assurance audits, consulting, and solutions management activity; improve the effectiveness of Alphabet’s governance, risk management, and internal control activities. * Manage work requirements and budget to meet team initiatives; communicate with and educate process owners effectively, including non-finance individuals, on the importance of controls, an effective control environment and the role of the audit team. * Manage third-party service providers or external subject matter experts in planning and conducting audits. * Perform risk assessments, prioritize initiatives and determine resource needs. * Communicate with and educate process owners, including non-finance individuals, on the importance of controls, an effective control environment, and the role of Internal Audit. ## Qualifications Minimum qualifications: * Bachelor's degree in Business, Finance, Accounting, or Law or equivalent practical experience. * 9 years of relevant work experience in an audit role working with regulatory compliance (e.g., FCPA/Anit-Bribery, HIPPA, Trade Compliance, EH&S;, etc.). Preferred qualifications: * Certified Public Accountant, Chartered Accountant, Certified Internal Auditor, Juris Doctor, Master of Laws, or related experience. * Ability to navigate through ambiguity, manage and coordinate multiple project assignments simultaneously in a fast-paced, deadline-driven environment, accepting ownership and accountability of the process and deliver on commitments. * Ability and willingness to take initiative to address problems and make continuous process improvements. * Leadership skills with ability to take charge, confidence to interact with all levels, set objectives, drive results, and a team player; ability to work with a wide variety of departments. * Exceptional written and verbal communication skills. * * * At Google, we don’t just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products and our community. Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you have a disability or special need that requires accommodation, please let us know. To all recruitment agencies: Google does not accept agency resumes. Please do not forward resumes to our jobs alias, Google employees or any other company location. Google is not responsible for any fees related to unsolicited resumes. Google Inc. Sunnyvale CA

IT Compliance Manager

Pharmacyclics