Position Summary:
On behalf of Acadia GmbH the Sr. Manager, Quality Assurance Operations will be responsible for oversight of cGMP European operations within a global Quality Assurance department of Acadia Pharmaceuticals Inc. Responsibilities will include oversight of assigned cGMP operations performed at Contract Manufacturing Organizations (CMOs), as well as cGMP European operations performed at Acadia, quality release of API and drug product, raw materials and intermediates intended for commercial and clinical (where required) use. Primary responsibilities include: batch record review and batch disposition, support of product complaints, annual product review / product quality reviews, continuous process verifications (CPV), ensuring conformance to global Acadia standard operating procedures (SOPs) and quality agreements with CMOs, as well as compliance to Swissmedic/EMA/MHRA and other applicable international regulations. Proficient-level user and participant in continuous improvement activities with respect to Acadia global GMP training program, change management, validation activities, batch review and release, complaint handling, CAPA program, GMP audits, and similar related activities. This position reports to the Director, Quality Assurance, Acadia GmbH.
Primary Responsibilities:
- Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.
- Manages the Acadia batch disposition process of API, Drug Product, Raw materials and Intermediates
- Participates in design, implementation and management of the Acadia GMP quality management system, based on Swissmedic/EMA/MHRA and other applicable international regulations
- Ensures compliance of the Acadia GMP quality management system with Swissmedic/EMA/MHRA and applicable international quality management system regulations
- Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement
- Participates in GMP supplier audits and Acadia documentation control systems as needed
- Manages and/or provides oversight to QA personnel involved with CMO technology transfer, process validation, batch documentation, registration batch review and process changes and deviations
- Participates in the review of, and ensures conformance to Quality Agreements with GMP contract service providers for outsourced operations
- Manages internal investigations and change management and establishes effective CAPA plans and ensure oversight on CMOs investigation and change management activities.
- Participates in and/or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards
- Ensures adequate QA representation on all GMP product development teams; provides direction to QA representatives on these teams
- Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect
- Participates in Quality Operations functions such as: Material Review Board, quality board, strategic planning efforts, etc., as may be required
- Participates in formal risk assessment activities as required
- Develops and/or contributes metrics to support product and/or process review efforts as needed
- Develops department goals and objectives for senior management review in alignment with Acadia strategic planning
- Other duties as assigned/required
Education/Experience/Skills:
Pharm D, Master´s or Bachelor’s degree in Chemistry/Biology/Pharmacy or related life science is required. A minimum of 5 years related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry.
- Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and Swissmedic/EMA/MHRA and other international GMP regulations as they relate to clinical trials, product development, commercial requirements and technology transfer
- Demonstrated proficiency in interpretations of cGMP regulations for Swissmedic/EMA/MHRA and other international regulations.
- Experience implementing and managing quality management systems is an advantage
- Experience conducting internal and supplier audits and manufacturing facility inspections is an advantage
- Ability to interpret and relate Quality standards for implementation and review
- Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize
- Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
- Able to gain cooperation of others
- Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals
- Able to make and prioritize process and resource decisions based on overall team needs
- Experience in a global organization; ideally in the EU or Switzerland
- Fluent in spoken and written English (additional European language(s) an advantage)
- Travel 25-40% may be required (including international)
Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business issues.
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 race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
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