Associate Director, Quality (QMS) at Acadia Pharmaceuticals

King of Prussia, Pennsylvania, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Emulates Paratek's core values - Passionate, Resourceful, Collaborative, Purposeful
Bachelor's degree in chemistry, biology, or related discipline
Practical experience for at least 15 years in the pharmaceutical industry specifically in the manufacturing/technical/QA functions
At least 10 or more years of direct QMS QA experience required
Experience working with Service Providers and with managing QTAs, conducting site audits, completing APRs
Strong current knowledge of local and international regulatory and legislative requirements to ensure that technical support on all quality related matters is provided
Familiarity with Field Alert Reporting and participation in Health Authority inspections
Logical problem solver who can remediate issues in a timely manner
Excellent organization, written/verbal communication and attention to detail
Good self-starter, ability to work independently

Responsibilities

Provide leadership and oversight for all QMS processes
Drive collaboration within internal cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed-upon metrics and business goals
Represent Quality at key internal and external meetings
Ensure execution of the QMS related to document development, review and approval as applicable to ensure compliance is achieved and maintained
Ensure annual training is completed on time
Ensure annually all procedural documents are written/reviewed/approved
Ensure annually all Annual Product Reviews (APRs) are written/reviewed/approved
Ensure that Quality Technical Agreements (QTAs) with Paratek suppliers are established, maintained, implemented
Establish an annual master audit plan
Ensure the Qualified Service Provider List (QSPL) is reviewed and updated routinely
Audit Service Providers and manage all initial and follow-up activities
Perform and participate in internal and external cGxP audits as required, including PAI readiness
Conduct review of completed GxP audits to identify systemic trends requiring action
Participate in internal and external cGxP Health Authority inspections
Directly interact with GxP Service Providers to drive remediation as needed
Support pharmacovigilance QA activities
Support/lead FDA field alerts, Product Recalls/Withdraws
Lead continuous improvement initiatives to enhance product and service quality
Oversee, manage, and update the Quality Management System (QMS) to ensure it remains fit for purpose
Organize, conduct, oversee, track and trend internal and external audits
Provide service provider management through writing/reviewing/approving QTAs, APRs, supplier qualification forms, etc
Write/review/approve quality incidents such as deviations, FDA field alerts, product recalls
Generate metrics as needed
Provide pharmacovigilance QA support and support Health Authority Inspections

Skills

Key technologies and capabilities for this role

QMSQuality Management SystemAuditsQTAsAPRsSupplier QualificationDeviationsProduct RecallsPharmacovigilance QAHealth Authority InspectionsTraining ManagementDocument ReviewMetrics Generation

Questions & Answers

Common questions about this position

What is the work location and arrangement for this role?

The position is located in King of Prussia, PA, with a hybrid work arrangement.

What experience and education are required for this position?

Candidates need a Bachelor's degree in chemistry, biology, or related discipline and at least 15 years of practical experience in the pharmaceutical industry.

What are the company's core values that candidates should emulate?

Paratek's core values are Passionate, Resourceful, Collaborative, and Purposeful.

What is the salary range for this Associate Director role?

This information is not specified in the job description.

What makes a strong candidate for this Quality position?

A strong candidate will have 15+ years of pharmaceutical experience, a relevant Bachelor's degree, and embody Paratek's core values of being Passionate, Resourceful, Collaborative, and Purposeful, with expertise in QMS oversight, audits, and compliance.

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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