Crinetics Pharmaceuticals
Senior Specialist, Quality Assurance GCP
Crinetics Pharmaceuticals, San Francisco, California, United States, 94199
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:The Senior Specialist, Quality Assurance GCP will support the Good Clinical Practice (GCP) quality oversight and compliance program at Crinetics Pharmaceuticals.
Essential Job Functions and Responsibilities:These may include but are not limited to:
Plan, oversee, conduct, and report assigned GCP routine audits (clinical investigator site, vendors, system/process, TMF, data, and clinical documents)Provide GCP guidance and support for research and development activities; participate in clinical study team meetings and discuss clinical study related compliance topicsCreate, revise, and implement quality SOPs or Work InstructionsAssist in development of processes related to GCP complianceReview of CAPAs and deviations; perform root cause analysis an investigationsSupport regulatory inspections and inspection-readiness activitiesDevelop and maintain professional cross-functional and cross-departmental relationships; foster a collaborative environment with cross-functional teamsComplete assigned training requirementsSupport other quality driven activities and initiatives; work cross-functionally to identify and mitigate potential clinical quality compliance risksReview of clinical study documentsIdentify trends in quality events and reports issues and deficienciesSupport and drive continuous process improvement activitiesInterpret and apply regulations of moderate complexityFoster an environment that supports GCP complianceCoordinate and administer GCP trainingIdentify and escalate significant compliance risks to senior managementMaintain and archive QA electronic files and documentationEducation and Experience:Required:
Bachelor's degree with 5 years of quality assurance experience, or an equivalent combination of experience and education may be consideredGCP auditing and compliance experienceKnowledge of FDA and ICH GCP and other global regulationsKnowledge working with QMS in vendor management, SOPs, internal audits, CAPAs and deviationsDemonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous componentsCollaboration, communication, and interpersonal skillsExcellent verbal and written communication skillsOutstanding organizational, prioritization, and detail-oriented skillsUnderstanding of organization policies, procedures, and guidelinesPreferred:
Regulatory inspection experience highly desired
Physical Demands and Work Environment:Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Travel:You may be required to travel for up to 15% of your time.
The Anticipated Base Salary Range:
$83,000-$110,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Vaccination requirement:Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
Position Summary:The Senior Specialist, Quality Assurance GCP will support the Good Clinical Practice (GCP) quality oversight and compliance program at Crinetics Pharmaceuticals.
Essential Job Functions and Responsibilities:These may include but are not limited to:
Plan, oversee, conduct, and report assigned GCP routine audits (clinical investigator site, vendors, system/process, TMF, data, and clinical documents)Provide GCP guidance and support for research and development activities; participate in clinical study team meetings and discuss clinical study related compliance topicsCreate, revise, and implement quality SOPs or Work InstructionsAssist in development of processes related to GCP complianceReview of CAPAs and deviations; perform root cause analysis an investigationsSupport regulatory inspections and inspection-readiness activitiesDevelop and maintain professional cross-functional and cross-departmental relationships; foster a collaborative environment with cross-functional teamsComplete assigned training requirementsSupport other quality driven activities and initiatives; work cross-functionally to identify and mitigate potential clinical quality compliance risksReview of clinical study documentsIdentify trends in quality events and reports issues and deficienciesSupport and drive continuous process improvement activitiesInterpret and apply regulations of moderate complexityFoster an environment that supports GCP complianceCoordinate and administer GCP trainingIdentify and escalate significant compliance risks to senior managementMaintain and archive QA electronic files and documentationEducation and Experience:Required:
Bachelor's degree with 5 years of quality assurance experience, or an equivalent combination of experience and education may be consideredGCP auditing and compliance experienceKnowledge of FDA and ICH GCP and other global regulationsKnowledge working with QMS in vendor management, SOPs, internal audits, CAPAs and deviationsDemonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous componentsCollaboration, communication, and interpersonal skillsExcellent verbal and written communication skillsOutstanding organizational, prioritization, and detail-oriented skillsUnderstanding of organization policies, procedures, and guidelinesPreferred:
Regulatory inspection experience highly desired
Physical Demands and Work Environment:Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Travel:You may be required to travel for up to 15% of your time.
The Anticipated Base Salary Range:
$83,000-$110,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Vaccination requirement:Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.