Quality Management Systems Supervisor

2 weeks ago

Wilmington, North Carolina, United States AAIPharma Full time
Job Summary:

The Supervisor, Quality Management Systems, oversees and coordinates the activities of an assigned team, providing technical leadership in Quality Systems, Documentation Systems, and administration of the eQMS. This role involves coaching, training, and developing the skills of subordinate staff, as well as interacting with external clients and vendors to successfully meet client and departmental objectives.


Key Responsibilities:

  • Represent the department in meetings, collaborate, and cooperate to achieve cross-functional improvements and business goals.
  • Create departmental systems and foster a culture of continuous improvement focused on value to the customer.
  • Manage the day-to-day operations for assigned areas, ensuring all staff members are fully trained.
  • Actively participate and contribute to the preparation and support of client and internal audits as well as regulatory inspections.
  • Recruit, train, develop, and retain staff for the effective process of departmental operations.
  • Provide technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
  • Effectively resolve related technical/business-related and/or quality issues and concerns in a timely manner.
  • Create strong and effective relationships with internal and external clients.
  • Maintain a high level of professional and technical/business expertise through participation in training courses.

Requirements:

  • Bachelor's degree required.
  • 4+ years applicable experience.
  • 1 to 2+ years in leadership roles.
  • Applicable experience in operational areas may require experience to be a CDMO or regulated area.

Skills and Abilities:

  • Basic business acumen.
  • Effective listening skills with the ability to listen attentively and process and relay information correctly.
  • Good verbal and written communication and documentation skills required.
  • Highly effective team and interpersonal skills with the ability to work across numerous management disciplines.
  • Good analytical and problem-solving skills, with the ability to think strategically.
  • High level personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
  • Highly goal and result-oriented.
  • Treats colleagues at all levels with respect.
  • Good detail orientation and organizational skills required.
  • Able to troubleshoot and solve basic and moderately complex problems.
  • Strong technical skills for area managing.
  • Good knowledge of cGMP in a pharmaceutical or regulated environment.
  • Good knowledge of FDA, EU, and ICH requirements and implementation in the pharmaceutical industry based on area being managed.
  • Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites, for cGMP areas.
  • Understands how to prioritize tasks according to business objectives and can pursue several objectives simultaneously.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
  • Proficiency and experience with eQMS platforms, MasterControl preferred.

Travel Expectations:

  • Up to 15% travel may be required.

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