Senior Manager, Quality Control

Role Summary

Senior Manager, Quality Control – Based in San Diego, CA with a hybrid work model (office three days per week).

Responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products, and for coordinating with CSPs performing GMP analytical testing. Includes review of release testing and stability data for DS and DP and preparation of regulatory submission documents.

Responsibilities

• Review and evaluate analytical test results for DS and DP
• Review and author analytical method protocols and validations for commercialized products
• Review and author analytical transfer protocols and reports between laboratories
• Author stability protocols and reports, including trending analysis of all data
• Negotiate and/or review stability related agreements
• Author and review analytical data summaries to support batch release and stability assessments
• Assist in the review of reports for regulatory filings
• Interact with CSPs to facilitate stability testing at contract laboratories for Acadia projects
• Coordinate stability studies including reporting of test results
• Familiar with extractable and leachable testing, container closure and packaging qualification and integrity testing, and cleaning verification method development and validation
• Conduct and document analytical deviations, OOS/OOT investigations, and CAPA reports following SOPs and GMP guidelines
• Maintain training records per GMP training requirements
• Work effectively in a changing environment and manage scheduling to meet timelines
• Collaborate with staff and CSPs; assist with data review at CSPs; assist with routine GMP audits of CSPs

Qualifications

• Required: BA/BS in chemistry or biochemistry with 8 years of pharmaceutical industry experience
• Proficiency in analytical science; experience reviewing DS and DP release and stability data (desired)
• Experience with stability, method development, validation and transfer
• GMP environment experience (Quality Control and/or Quality Assurance)
• Experience documenting deviations and investigations in GMP systems
• Excellent written and verbal communication and interpersonal skills
• Experience with CMC sections for regulatory filings
• Strong negotiation, organizational, and multitasking abilities; proactive and detail-oriented
• Contract service provider experience required
• Must possess: Analytical Chemistry Manufacturing Controls (CMC) experience; GMP knowledge; analytical development, validation and testing; laboratory instruments knowledge (HPLC, GC, KF, IR, etc.); statistical modeling experience
• Ability to travel up to 20% domestically and internationally

Skills

• Analytical method development, validation, and transfer
• Stability testing and data trending
• GMP QA/QC practices; regulatory documentation
• Laboratory instrumentation: HPLC, GC, KF, IR, etc.
• Statistical analysis and modeling
• Contract GMP auditing and CSP management

Education

• BA/BS in chemistry or biochemistry (required)

Additional Requirements

• Travel: up to 20% domestically and internationally
• Physical requirements are not listed as essential to the role beyond standard occupational activities