Senior Quality Auditor at Acadia Pharmaceuticals

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Bachelor’s degree in a scientific discipline
Minimum 10 years’ experience in Quality Audits and/or supporting GCP/GLP/GPV/GCLP audits and activities in the drug development industry with knowledge of FDA, EMA, MHRA and other applicable global regulations (experience with other GxP such as GMP, GDP is a plus)
Excellent verbal and written communication skills
Demonstrated ability to influence across the organization
Successful experience writing and reviewing SOPs and other Quality documents
Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical and commercial products
Demonstrated ability to successfully interact with regulatory health authorities during inspections
Thorough understanding of audit programs
Excellent organizational skills with ability to manage multiple tasks of varying complexity simultaneously
Strong interpersonal skills including relationship building and conflict resolution
Experience with Veeva platform systems is a plus
Ability and willingness to travel domestically and internationally up to 40-50% of time

Responsibilities

Act as Quality Auditor Lead on GCP/GLP/GCLP/GPV Audits by performing Internal and External Vendor Audits as scheduled
Support development of audit management plans and audit strategy for ongoing Internal and Vendor Audits
Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
Support or conduct training for staff (GCP, GLP, GCLP, GPV)
Support both Regulatory Inspections and Partner Audits of Mirum as needed
Review/revise Standard Operating Procedures (SOPs) and procedures as assigned
Support the day-to-day activities of the audit programs, including but not limited to audit coordinating, report reviews, response review, CAPA follow-up, and audit close-out as needed
Gather data for accurately tracking, reporting, and analyzing metrics, as required
Support GxP inspection readiness activities, as applicable
Other duties as assigned

Skills

Key technologies and capabilities for this role

GCPGLPGCLPGVPInternal AuditsExternal AuditsVendor AuditsCAPAAudit ReportsSOPeQMSRegulatory InspectionsTraining

Questions & Answers

Common questions about this position

What experience is required for the Senior Quality Auditor position?

A minimum of 10 years’ experience in Quality Audits or supporting GCP/GLP/GPV/GCLP audits in the drug development industry is required, along with knowledge of FDA, EMA, MHRA, and other global regulations.

What education is needed for this role?

A Bachelor’s degree in a scientific discipline is required.

What key skills are essential for this position?

Excellent verbal and written communication skills, demonstrated ability to influence across the organization, and successful experience writing and reviewing SOPs and other Quality documents are essential.

What is the company culture like at Mirum Pharmaceuticals?

The company values collaboration, creativity, and experience, with core values of care, be real, get it done, and have fun, seriously.

What is the salary for the Senior Quality Auditor role?

This information is not specified in the job description.

Is this position remote or office-based?

This information is not specified in the job description.

What are the main responsibilities of this role?

Responsibilities include acting as Quality Auditor Lead on GCP/GLP/GCLP/GPV audits, supporting audit management plans, reporting findings, conducting training, reviewing SOPs, and supporting inspection readiness.

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

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