Manager, Quality Assurance at Acadia Pharmaceuticals

Tokyo, Japan

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Experience in GQP/QA operations in pharmaceuticals, including GAP analysis (SOGO TENKEN), change management, quality documentation, deviation and complaint management
Knowledge of GxP regulations in Japan (e.g., GQP and GMP ordinances) and global GxP guidelines, corporate policies, standards, and SOPs
Ability to oversee local CMOs, overseas manufacturing sites (internal and external), and supplier quality management (SQM)
Skills in cross-functional collaboration with SCM, RA, CMC, and global teams
Strong English and cross-boundary communication skills for daily quality operations and OJT
Leadership capabilities for strategic projects, with potential for succession to roles like Head of Quality or Quality Responsible (GQP-Hinseki)
Experience in new product launches, quality transformation, and assessing quality/regulatory impacts of changes (e.g., site transfers, expansions, process modifications)

Responsibilities

Conduct GQP operational roles for Ferring products under MAH, including GAP analysis between regulatory files and actual manufacturing/testing activities
Manage local change management activities, quality documentation, deviations, and complaints
Provide oversight of local CMOs and overseas manufacturing sites (internal and external)
Handle supplier quality management (SQM) and ensure compliance with Japanese GxP regulations, global guidelines, and company policies
Lead and manage strategic projects from a quality perspective, such as Local CMO Optimization Project (assess CMOs, provide GMP guidance, maintain communication)
Collaborate with local SCM team to identify suitable CMOs through structured assessments
Perform preliminary assessments and early-stage project preparation for potential changes at manufacturing sites, including cross-functional investigation and communication of quality/regulatory impacts
Support new product introductions under GQP control and contribute to quality operations for product portfolio in specialized therapeutic areas

Skills

Key technologies and capabilities for this role

Quality AssuranceGMPQMSGQPChange ControlCMCRegulatory AffairsSupply Chain Management

Questions & Answers

Common questions about this position

What is the salary or compensation for this Manager, Quality Assurance role?

This information is not specified in the job description.

Is this position remote or does it require working in an office?

This information is not specified in the job description.

What key skills are required for the Manager, Quality Assurance position?

The role requires expertise in GQP operations, change management, deviation and complaint management, oversight of manufacturing sites and CMOs, and supplier quality management, along with compliance knowledge of GxP regulations, GMP ordinances, and global guidelines.

What career growth opportunities are available in this role?

The position offers high visibility, leadership opportunities, English and cross-boundary communication skills development, and potential to become successor for key positions like Head of Quality or Quality Responsible (GQP-Hinseki).

What makes a strong candidate for this Quality Assurance Manager role?

Strong candidates will have capabilities in GQP operations, strategic project leadership, cross-functional collaboration with teams like SCM, RA, and CMC, and the potential for development into key leadership positions.

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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