The Manager - Quality is responsible for independently performing domestic and international inspections that ensure compliance to the FDA and other worldwide health authority cGMP regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides suggestions for recommendations for corrective and preventative action to the Quality Senior Management team. Tracks commitments until closure. PLEASE REFER TO JOB CODE 18012 WHEN APPLYING FOR THIS POSITION
*Essential Duties and Responsibilities include the following. Other duties may be assigned.:
• Independently plans and conducts routine document and internal audits. Routine review of documentation includes but is not limited to batch records, protocols, reports, certificates of analysis, product complaints.
• Presents QA findings, independently, to in-house client staff and, if appropriate, to the responsible individuals at service providers.
• Recommends corrective and preventative action of compliance concerns and reviews implementation of corrective and preventative actions.
• Plans and conducts domestic inspections.
• Participates in the planning and conducting process of international inspections.
• Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate.
• Reviews internal SOPs; reviews external SOPs with minimal supervision.
• Tracks metrics and trends as well as compliance issues and their resolution on a periodic basis.
• Participates on Process Improvement teams.
• Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures.
• Maintains Quality documentation files, databases and logs.
• Ensures project deadlines and performance standards are met.
• Ensures compliance with all of Acorda policies and procedures including safety rules and regulations.
• Acts as support during compliance inspections conducted by external sources (i.e. health authorities) at Acorda, as applicable.
• Evaluate corrective and preventative action responses to audit findings for adequacy and timeliness and manage the closeout of all corrective and preventative actions.
• Provide audit related metrics to Senior Management.
Education and/or Experience:
• Bachelor's degree in life sciences or related field required.
• Master's degree in life sciences or related field preferred.
• Minimum of six years experience in the regulatory compliance environment.
• Minimum of four years auditing experience in the Biotechnology or Pharmaceutical industries required.
• Prior experience with the Biotechnology or Pharmaceutical industries preferred.
Supervisory Responsibilities: :
• Strong knowledge of GCP, GLP, or cGMP concepts.
• Knowledge and understanding of the approach and perspectives of regulatory agencies.
• Must be able to interpret and apply GCP regulations and guidances with supervision.
• Therapeutic experience and knowledge of Multiple Sclerosis preferred.
• Strong knowledge of FDA, EMA and ICH GMP requirements.
• Must be proficient in MS Office Suite.
Certificates, Licenses, Registrations: :
Other Skills and Abilities::
• Excellent verbal and written communication skills.
• Ability to manage both day-to-day operations as well as project work in a fast paced environment.
• Ability to work both independently and in a collaborative team setting.
• Ability to multi-tasks and adjust priorities, as necessary.
• Ability to effectively present information to management.
Location: Corporate Office:
This position requires the ability to work on-site 5 days per week in the corporate office in Ardsley,NY.
Physical Demands: :
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• The average travel for this position is 25% with some variation based upon the demands of the business imperatives. Travel is to both domestic and international locations in support of audit activities.
Work Environment: :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.