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Quality Assurance and regulatory affairs Manager

The Quality Assurance and Regulatory Affairs Manager (QA/RA Manager) is responsible for implementing, overseeing, and ensuring ongoing compliance with regulatory affairs and quality assurance requirements and regulations. The QA/RA Manager is also responsible for interacting and leading the Quality Assurance & Regulatory Affairs teams to accomplish the business objectives and performing to operational objectives. The QA/RA Manager must monitor and ensure implementation of goals to meet established quality assurance, quality control, and quality improvement. This role will also be responsible for facilitating FDA inspections, including quality evaluations as well as ensuring compliance with regulatory agency requirements through maintaining proper documentation, conducting audits, and corrective actions. This position requires an appropriate level of accountability for decision making and clear communication skills.

Role and Responsibilities

  • Supervise Quality Assurance and Regulatory Affairs teams.
  • Responsible for completion of all employees’ responsibilities within the Quality Assurance and Regulatory Affairs teams.
  • Support the Quality Assurance & Regulatory Affairs teams in personal development and in determining training needs.
  • Provide training to Quality Assurance and Regulatory Affairs teams.
  • Research Quality Assurance, Regulatory Affairs, Chemistry and Microbiology information regarding USP, FDA, ICH, and ISO guidelines, as well as other important resources.
  • Responsible for keeping abreast with FDA and DEA regulations.
  • Responsible for conducting internal audits.
  • Responsible for facilitating audits and inspections from regulatory agencies.
  • Review audit letters and responses.
  • Provide companywide CGMP and other required regulatory training.
  • Review Certificates of Analysis.
  • Write and review Standard Operating Procedures and ensure compliance with current regulatory requirements.
  • Write, review, and maintain Corrective and Preventative Action program documentation.
  • Review of all Quality Control documentation and data, as required.
  • Review test results prior to release, as required.
  • Participate in personal development and supervisory training classes.
  • Work as a team: Departmental collaboration to achieve a common goal or to complete a task in the most effective and efficient manner.
  • To accommodate business needs, which includes understanding how to prioritize daily tasks and be efficient with managing your time.
  • Perform other tasks as specified by the Chief Executive Officer.

The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.

QUALIFICATIONS

  • Bachelor’s Degree in Biological or Health Sciences.
  • At least 6 years of experience in the pharmaceutical industry and managing/leading teams.
  • Experience management of multiple projects for different departments.
  • Effective communication and presentation skills.
  • Ability to work independently, prioritizes multiple projects, addresses multiple issues and handles multiples deadlines.
  • Solid decision-making skills, team orientation and high degree of initiative.
  • Computer competency with experience in Microsoft Office.
  • Authorized to work in the U.S. of America.

WORK CONDITIONS AND PHYSICAL REQUIREMENTS

The Quality Assurance and Regulatory Affairs Manager may require working additional hours to meet project deadlines and will travel occasionally to attend seminars, conferences, or trainings.

  • Wear proper protective equipment.
  • Sometimes exposed to loud sounds or distracting noise levels.
  • Are often exposed to contaminants or hazardous conditions while conducting analyses.
  • Work within several feet of others in the laboratory.
  • Sit or stand for an extended period.
  • Be able to lift objects up to 25 pounds.
  • May have to crawl or climb to perform certain tasks like maintenance of an instrument.
  • Repetitive tasks with few breaks.

DIRECT REPORTS

This position provides work direction and gives input on hiring, promotions, transfers, performance management, discipline, and termination.

  • Quality Assurance Assistant Manager
  • Regulatory Affairs Supervisor
  • Quality Assurance Associate
  • Quality Assurance Assistant
  • Regulatory Affairs Associate
  • QA/QC Coordinator

Note: The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.