Sr. Manager Quality Control, EU

Über diese Stelle

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

Position Summary:

The Sr. Manager, Quality Control EU plays a key role in the quality direction of analytical methods and specifications used to test and release Acadia’s products outside North America. This position is responsible for the establishment of commercial analytical methods used to support manufacturing, release, and stability testing that is conducted at multiple Acadia drug substance (DS) and drug product (DP) Contract Service Providers (CSPs) as well as the review of analytical method validations/transfers between laboratories outside North America. The role is responsible for the analytical review of release testing and stability data of DS and DP and coordinates efforts with CSPs to report and trend analytical test results in a timely manner. The position supports the quality review of analytical technical reports and documents intended for regulatory submissions.

Primary Responsibilities:

• Review and approve analytical test results for DS and DP

• Review and/or author analytical method protocols, validations and analytical sections of annual product quality reviews for commercial products

• Review and/or author analytical transfer protocols and reports between laboratories

• Author stability protocols and reports

• Negotiate stability related agreements

• Actively monitor stability programs at CSPs

• Author and/or review analytical data summaries to support batch release and stability assessments

• Assist in the review of reports for regulatory filings

• Support and participate as needed during inspections of local health authorities

• Direct CSPs to facilitate stability testing at contract laboratories for Acadia projects

• Coordinate stability studies including reporting of test results

• Report stability data/trending to senior management

• Liaises with manufacturing, quality and regulatory counterparts to develop stability protocols for regulatory submissions

• Liaises with project teams to identify intermediates, DS and DP batches required to be added to stability programs

• Conduct and document analytical deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and CAPA reports following SOPs and GMP guidelines

• Lead analytical data review at CSPs

Education/Experience/Skills

• Bachelor’s degree in a Health Science discipline required, Master’s degree preferred. Equivalent combination of relevant education and applicable job experience will be considered.

• Minimum 3-5 years of experience within the pharmaceutical manufacturing industry with focus on quality control/quality assurance

• Strong knowledge of EU, JP, and FDA GMP regulations, ICH guidelines as well as other relevant regulatory requirements

• Proven experience managing outsourced GMDP activities

• Strong organizational and project management skills with the ability to manage multiple projects simultaneously

• Excellent attention to detail and commitment to quality.

• Effective negotiation and stakeholder management skills.

• Ability to independently assess complex situations, resolve issues, and recommend practical solutions.

• Strong risk-based decision-making and problem-solving capabilities.

• Excellent written and verbal communication skills with the ability to convey complex information to diverse audiences

• Demonstrated ability to build collaborative relationships and work effectively across functions and external partners with flexible working hours.

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 9 kilograms. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages

• Medical, dental, and vision insurance

• Employer-paid life, disability, business travel and EAP coverage

• 401(k) Plan with a fully vested company match 1:1 up to 5%

• Employee Stock Purchase Plan with a 2-year purchase price lock-in

• 15+ vacation days

• 13 -15 paid holidays, including office closure between December 24th and January 1st

• 10 days of paid sick time

• Paid parental leave benefit

• Tuition assistance

EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of…