Job Listings

·        The IT Quality Engineer (QE) Lead/Manager resides in the IT QSC Operations group, and performs and provides expertise in various QSC operational areas: coordination, and execution of corporate wide IT policy and procedures in accordance with SOX, FDA (GxP), Intellectual Property, international and local privacy requirements and internal company procedures.
·        The QE supports SOX operations, computer system validation, change control, issue management, document control and IT process training operations.
·        The QE demonstrates leadership and independence in managing key Quality System processes and SOX testing activities.
·        The QE develops process performance indicators, identifies and interprets process operational trends, and leads/drives continuous process improvement.
·        The QE interacts with members from the QSC Engineering group, business units, Internal Audit, Quality Assurance and IT technical groups to develop and execute a risk-based program to ensure the integrity, confidentiality and security of high value and sensitive data.

·     Development of operational key performance indicators, identify trends, and feedback of trends and requirements to QSC Engineering
·     Driving continuous process improvement with QSC Engineering
·     Support of daily operations of SOX systems, computer system change control, issue management, and IT process training operations for various user departments.
·     Management of key quality system process, quarterly and annual SOX testing activities.
·     Leading the development and documentation of User, Functional and Design requirements; Installation, Operational and Performance Qualification; acceptance criteria; Standard Operating Procedures; requirements traceability, Infrastructure Qualification and change control.
·     Execution of qualification/validation activities in accordance with the requirements, master plans, procedures and protocols.

·    Bachelors degree in Science or Technology, Masters or higher preferred.
·    10+ years experience in pharmaceutical processes including systems lifecycle processes, change control, CAPA, SOX or computer validation.
·    Exceptional interpersonal skills, including teamwork, facilitation, and negotiation. Demonstrated experience organizing ad hoc teams to achieve excellent results.
·    Excellent planning and organizational skills. Persuasive writer with strong verbal communication skills.
·    Demonstrated commitment to integrity and ethics in business transactions and relationships.
·    Demonstrated ability to apply technical knowledge to the promotion of system quality.
·    Leadership and project management skills. Excellent analytical, problem-solving and technical skills. Detail oriented, systematic and rapid learner.
·    Accountable self starter with the ability to handle multiple tasks simultaneously and effectively with limited oversight.

Kevin Walker |ANR Consultants

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650-396-7356