Senior Manager, Quality Audits and Compliance

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

This role will work closely with internal QA leads/stakeholders and external suppliers to assist in the planning, scheduling, conducting, and leading all aspects of GxP audits. They will collaborate internally and externally with clinical investigator sites, Contract Research Organizations (CRO), and Contract Service Providers (CSPs) for studies and activities in compliance in Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), and Good Manufacturing (GMP). This individual will also support audit/CAPA activity timeline management, review of proposed audit observation/CAPA responses and proposed actions as well as Quality support across various functions.

Primary Responsibilities

• Manage, track, and lead GxP audits to assure CSPs and CROs are alignedwith Acadia's expectations, standards, and applicable domestic and international laws and regulations.
• Prepare and review audit reports, and ensure observations are adequately responded to and addressed.
• Assist in creation, maintenance and updating audit schedules.
• Ensures compliance with quality regulations procedures, systems and processes, are effective and meet FDA/Eudralex/Canadian/ICH requirements and applicable domestic/international regulations.
• Maintain and support the internal audit programs.
• Lead all aspects of the creation and maintenance of Quality Agreements with applicable GxP CSPs.
• Compile and manage audit metrics to facilitate management review and identify continuous improvement areas.
• Provide compliance expertise and advise as and where needed.
• Support the establishment and ongoing continuous improvement, validation, and maintenance of quality system related computer software solutions.
• Support continuous improvement activities aligned with cGxP and current industry standards.
• Recommend changes and establish applicable new procedures (e.g. SOPs, Work Instructions) that affect the functional area and may also have company-wide effect.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• 30-50% travel requirement 
• Other duties as assigned.

Education/Experience/Skills

• Requires a Bachelor’s degree in a related field.
• Targeting 8 years of dynamically responsible experience within Bio/Pharmaceuticals, with a proven understanding of external and internal auditing.
• Extensive knowledge of guidelines and international regulations that define GxP requirements.
• An equivalent combination of relevant education and experience may be considered.
• Solid understanding of standard processes in quality management in bio/pharmaceutical industry, or other relevant industries.
• Proficiency in interpretation and application of cGxP regulations, both US and international.
• Exposure to a broad range of product platforms (e.g. device/combination product, sterile/non-sterile) is beneficial.
• Proficiency in Microsoft Office suite
• Proven experience in time management and good email practice
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting technical presentations concerning specific projects or timelines.
• Collaborative and able to gain cooperation of others.
• Skilled at effectively leading cross-functional teams and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Strong attention to detail in prioritizing, scheduling, and meeting deadlines.
• Ability to work independently, take initiative and complete tasks to deadlines
• Excellent interpersonal, communication, analytical and organizational skills

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 and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.

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Last updated on Aug 21, 2024