The Associate Director will be responsible for maintaining and performing external and internal audits for Acadia’s growing portfolio.  This role will maintain compliance with the GMP regulations and manages Quality Agreements.

Primary Responsibilities

• Manage, coordinate, schedule, and perform compliance audits in GMP environments to assure Contract Service Providers (CSP) are in alignment with Acadia’s expectations, standards, and applicable domestic and international laws and regulations.
• Prepare and review audit reports; ensuring that observations are adequately addressed.
• Oversee the creation and maintenance of Quality Agreements with clinical and/or commercial CSPs.
• Compile and manage audit metrics to facilitate Management Review.
• Prepare, format, and/or review Standard Operating Procedures (SOP) as needed.
• Coordinate audit activities with GCP/GLP Quality.
• Ensures compliance with quality regulations procedures, systems and processes, are effective and meet FDA, Eudralex, and Canadian requirements and applicable international regulations.
• Maintain and support the internal audit program.
• Support annual product reviews.
• Support mock recall exercises / actual field alert or recall events.
• Provide compliance expertise and advise.
• Provide expertise and support for the establishment and ongoing continuous improvement and/or maintenance of quality system related computer software solutions.
• Provide CSV support as needed.
• Support continuous improvement activities according to GMP and current industry standards.
• Recommends changes to policies and establishes procedures 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.
• Other duties as assigned.

Education and Experience

• Bachelor’s degree in a Life Sciences or related field. MBA preferred.
• Targeting 8 years of progressively responsible experience within Quality Assurance (QA), including 3 years directly responsible for GMP QA, with strong knowledge of external and internal auditing.
• Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
• American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus.
• An equivalent combination of relevant education and experience may be considered.
• Thorough knowledge of best practices in quality management in pharmaceutical or biopharmaceutical industry, or other relevant industries.
• Demonstrated knowledge of QA activities and International Conference on Harmonization (ICH) and FDA/EU GMP regulations as they relate to clinical trials, product development, manufacturing, technology transfer and commercial.
• Proficiency in interpretation and application of cGMP regulations, both US and international.
• Exposure to a broad range of product platforms (e.g. device/combination product, sterile/non-sterile) is beneficial.
• Ability to achieve objectives with minimal oversight or direction.
• Experience implementing and managing quality management systems.
• Experience conducting internal and supplier audits and manufacturing facilities inspections.
• Ability to interpret and relate Quality standards for implementation and review.
• 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.
• Collaborate and 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.

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 15 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule and/or business priorities.