Quality Assurance Manager/Associate Director - (DR-002) Ardelyx
THIS JOB HAS EXPIRED Ardelyx? develops therapeutics acting exclusively in the gastrointestinal tract and devoid of systemic
exposure. Our drug candidates target important diseases, as well as pathologies with a specific
inflammatory pathway. Our technology relies on non-absorbable small molecules with highly specific
modes of action. The quasi-absence of systemic uptake greatly reduces potential side effects and
toxicity while concentrating the drug at the locus of action, i.e. the GI tract. We are currently seeking a
highly motivated Quality Assurance professional to join our team.
At Ardelyx, you will experience an innovative and dynamic research and development environment. We
are seeking best-in-class scientists, advanced thinkers, and people who thrive on collaboration to cocreate the future. You will be working with some of the industry's best scientists in a team environment.
This individual will be directly responsible for the Quality Assurance function to support product
development. This person will be charged with establishing appropriate systems to maintain
compliance with applicable regulatory standards, including GMP, GCP and GLP. It is critical that quality
is built into the system and as such, it is expected that this individual will create flexible systems that
foster inter-departmental cooperation. Further, this person will have the opportunity to manage the
growth of these systems with accelerating product development. This position reports directly to the
Vice President, Drug Development. Job Code DR-002.
Specific Responsibilities include but are not limited to:
? Manage the systems and procedures that ensure compliance with applicable regulations (GLP,
? Ensure that Company procedures are consistent with development activities.
? Draft and implement appropriate standard operating procedures.
? Develop/maintain audit programs to satisfy contractual and regulatory requirements.
? Manage an internal audit function, if needed.
? Coordinate and/or conduct audits and routine QA inspections.
? Review CMC documents for regulatory compliance.
? Perform batch record reviews and product release.
? Ensure all QA reports are accurately produced in a timely manner; including deviation reports, OOS
? Establish needed GxP infrastructure (SOPs and Working Instructions)
? Establish and maintain adequate GxP training programs, as needed.
? Provide coordination and oversight, in conjunction with the CMC, Non-Clinical and Clinical.
Development departments for audit activities conducted with/by external vendors.Requirements
? Bachelor's Degree in Chemistry/Biology or related field is highly desirable
? 8+ years of experience.
? Experience in small molecule drug development.
? Ability to communicate with all level of personnel.
? Ability to appropriately interface with technical/scientific personnel.
? Self-motivated with ability to escalate issues appropriately
? Flexibility in the face of shifting priorities.
||34175 Ardenwood Boulevard |
Fremont, CA 94555
THIS JOB HAS EXPIRED