Senior Manager, Clinical QA Computer Systems at Achaogen
South San Francisco, CA, US
Position Summary:

Achaogen is seeking an experienced and highly motivated leader for the position of Sr. Manager, Clinical Quality Assurance (CQA) Computer Systems, reporting directly to the Director, CQA. The Sr. Manager is responsible for applying expertise in Good Clinical Practice (GCP)/Pharmacovigilance (PV) and international regulations to the process of QA oversight of GxP computerized systems. In addition, the Sr. Manager is responsible for building, promoting, and continually improving the CQA compliance program, based on a risk-based approach methodology, to be compliant with FDA, EU, ICH-GCP, and all other applicable health authority requirements. Moreover, this person works independently to address a variety of computer system compliance issues associated with drug development to ensure that automated systems and associated business processes meet both business needs and regulatory requirements. The individual should have an expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect computer systems compliance.

Essential Functions:

Define the CQA strategy for the oversight of regulated GCP/PV computer systems to ensure that these systems are implemented and maintained in conformance with relevant company policies and procedures, as well as regulatory expectations.
Manage CQA oversight on GCP/PV computerized system project and implementation teams.
Support the development and management of the CQA (GCP/PV) audit strategy, utilizing a risk-based methodology.
Participate in various development teams to ensure provide risk-based options of clinical development compliance risk are identified to ensure GCP/PV quality and compliance by acting as a source of advice and guidance.
Manage the execution of Capability/Due Diligence Audits of key software suppliers.
Schedule, conduct, and assist in external GCP/PV and in-house system audits, as well as lead audits of software vendors.
Participate in FDA, EU and applicable regulatory authorities and external auditors covering inspections and audits related to GCP and PV.
Assist the business areas in achieving compliance with 21 CFR Part 11, other applicable regulations, and Achaogen policies/procedures related to electronic systems compliance.
Conduct 21 CFR Part 11 assessments and assist the business areas and IT in developing corrective action plan.
Manage resources (internal and contracted staff) in the execution of requests for SME (CS technical) support of GxP computer systems audits.
Conduct training related to 21 CFR Part 11, validation, other regulatory agency regulations/guidance and Achaogen electronic system compliance related policies/procedures.
Work with business units to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained.
Other Duties as assigned.

Preferred Experience:

5-7 years of experience in computer systems quality and/or compliance in the Biotech, Pharmaceutical or Device/Diagnostics industry.
In-depth understanding of computerized systems used in the pharmaceutical/biotechnology industry, including their development lifecycle and intended use.
Extensive understanding of the quality systems required to managing the design, development, testing, and maintenance of computerized systems in a regulated environment.
Knowledge of the drug development process.
Knowledgeable of auditing and quality systems.
Knowledgeable of Pharmacovigilance systems and processes.
Regulatory compliance auditing, leading projects and team(s) experience preferred.
Experience in support of FDA, regulatory authority inspections and external audits.

Preferred Education:

Requires a BA/BS in Computer Science, Engineering or related discipline. An advance degree preferred.

Additional Skills:

Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment.
Ability to thrive in a matrix setting developing and maintaining collaborative internal and external relationships.
Good organizational, communication and presentation skills, effective project and time management skills, and able to work well under pressure.
Must be able to prioritize and re-prioritize on a continuous basis.
Must be highly organized and possess excellent attention to detail.
Must have strong oral, written and interpersonal communication skills.
Ability to make sound decisions about allocation of resources, and managing priorities.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Current US work authorization required.
Ability to travel up to 10% domestic and internationally.