Director, Quality Control at Acadia Pharmaceuticals

Parsippany, New Jersey, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Bachelor’s degree in a scientific discipline
15+ years of experience in pharmaceutical QC operations across development and commercial portfolios

Responsibilities

Provide strategic direction for the Quality Control department to achieve corporate and site-level objectives
Build and lead high-performing team
Coach, mentor, and engage team to ensure business goals and development plans are met
Oversee manufacturing unit operations, including review and approval of preventive maintenance activities and changes
Review and approve issues and investigations related to critical equipment, systems, and utilities
Establish and monitor operational metrics to track performance and identify trends
Develop and implement short- and long-term plans to ensure corporate and operational compliance with GxP standards
Ensure deployment and maintenance of quality processes aligned with regulatory requirements and internal policies
Manage planning and budgeting for Quality Control activities
Ensure third-party labs and CMOs comply with quality standards and regulatory expectations to meet product quality attributes
Provide QC oversight and approval of cGMP documentation (e.g., change controls, deviations, CAPAs, SOPs, validation protocols)
Lead or support QC-related projects and propose improvements using risk-based approaches
Maintain robust training programs to meet GMP and company requirements
Coordinate lab activities and actively participate in regulatory inspections, third-party audits, and customer audits
Monitor emerging regulatory requirements and assess organizational impact
Lead remediation efforts for identified gaps and drive continuous improvement initiatives
Perform other duties/projects as assigned by the Vice President, Technical Operations
Strategic leadership and oversight of the Quality Control (Analytical and Microbiology) function, including testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios
Partner cross-functionally with Pharmaceutical Development, Technical Operations, QA, and CMC Regulatory Affairs to manage method transfers, validations, and data oversight aligned with development and production timelines
Manage vendor oversight, data review, external audits, and GMP-related exceptions (e.g., deviations, CAPAs, OOS/OOT, change controls)
Oversee designation of critical quality attributes, specification setting, and trending of method and product performance
Provide direction on method transfers and validations, ensuring compliance with regulatory standards and laboratory control requirements

Skills

Quality Control

Analytical Testing

Microbiology

GMP

Method Validation

Method Transfer

Vendor Oversight

Data Review

External Audits

Deviations

CAPAs

OOS/OOT

Change Controls

Critical Quality Attributes

Specification Setting

Stability Testing

CMC Regulatory Affairs

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.

Land your dream remote job 3x faster with AI

Try Jobo Free