Senior Manager Quality Management Operations

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

The Sr. Manager is responsible for managing assigned Research and Development (R&D) Quality Operations activities, including quality oversight of R&D controlled documents (i.e. Standard Operating Procedures, Work Instructions) and R&D GxP and role-based training. Additional areas of support include inspection readiness and process improvement initiatives. Candidate will be required to work closely with internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs.  May oversee vendors for specific projects as necessary.  Collaborates within Quality on R&D’s use of controlled document and learning management processes and systems and identifies enhancements as needed.

Primary Responsibilities

• Maintains R&D training curricula and works with R&D leadership to ensure appropriate training based on job role and as defined in controlled documents.
• Creates new quality operations controlled documents and/or GxP training modules.
• Supports R&D controlled document owners as needed.
• Project manages assigned inspection readiness, process improvement, and/or quality operations projects. May lead specific projects as requested.
• Maintains GxP training modules to ensure they are kept up to date with revised regulatory requirements and/or internal procedures.
• Co-facilitates R&D’s process improvement program.
• Maintains quality operations and inspection readiness tools and templates.
• Contributes to ensuring compliance and quality oversight of R&D controlled documents and training.
• Stays up to date with regulatory requirements and reviews R&D controlled documents against regulations to ensure compliance.
• Assists to define R&D controlled document standards and ensures consistency across controlled documents.
• Collaborates within Quality on R&D’s use of controlled document and learning management processes and systems and identifies enhancements as needed.
• Other duties as assigned.

Education/Experience/Skills

Bachelor’s degree in a life science or related field.  Targeting 8 years’ experience within pharmaceutical or related industry, including 4 years’ in a controlled document/procedures, training, quality, compliance, or clinical/medical position in a GCP regulated environment.  An equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

• Experience with organizational change management, especially as it relates to embracing and promoting a culture of quality.
• Experience with Veeva Quality Docs and Compliance wire Learning Management System, or similar systems.
• Experience with applying adult learning principles to training development and ability to create and/or modify e-Learning courses.
• Training and application of process improvement methods, e.g. Lean Six Sigma.
• Project management certification a plus.
• Experience with multi-sized organizations from start-up to large employers.
• Experience with QA audits and Health Authority Inspections by FDA, EMA, MHRA, and PMDA.
• Familiarity with Central Nervous System (CNS) and/or Rare Disease therapeutic area a plus.
• Excellent communication skills, both verbal and written.
• Able to work independently as well as in cross-functional teams.
• Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.
• Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
• Skilled at working effectively with business partners and management, and appropriately signal and escalate matters of significance to the organization.
• Ability to travel up to 10% of the time.

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 needs.