Position Overview

The mission of the Ensera Director, Quality Assurance/Regulatory Affairs function is to implement repeatable and sustainable processes to ensure ongoing compliance with domestic and international regulations and standards. This includes implementing efficient and effective processes to ensure adherence to applicable regulations and standards.

Director, QA/RA is an independent self-starter, with strong understanding and experience in regulatory GMP Quality Systems who has a strong adaptability to navigate changing regulatory requirements and business priorities. Director, QA/RA is responsible for direction and coordination of all Quality System activities for Ensera. This position is responsible for compliance of the Quality Management System, including the support of any Ensera Global requirements, applicable Regulatory standards, and Customer requirements. This role may also provide hands-on quality support on the production floor as needed to ensure effective GMP oversight and continuity of operations.

Duties & Responsibilities

  • Implement and maintain effective Quality Assurance System in accordance with the requirements of 21 CFR Part 820, 210, 211, EU MDR, Polish GIF, EMA, cGMPs, ICH guidelines, and other relevant regulatory requirements.
  • Drive adherence to compliance by supporting all internal and external quality and regulatory requirements.
  • Report to top management on the effectiveness of the Quality Management System and any need for improvement.
  • Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all sites.
  • Establish quality team and individual goals and objectives in alignment with customer-focused team goals and customer requirements.
  • Define and implement adequate QA/RA organization, roles, responsibilities, and quality oversight.
  • Ensuring that QMS documents are regularly reviewed and up to date.
  • Proactively evaluate and routinely inspect for potential failure modes within the QMS, define improvements, and assure robust controls for areas of risk. Lead, identify, escalate, and implement compliant risk-based solutions for quality related issues to Executive and Group Quality Leadership.
  • Strict adherence to confidentiality of information provided by customers and protection of customer property.
  • Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines.
  • Ensure that assigned quality projects and targets are completed in a timely manner.
  • Provide support for Customer driven projects, including Regulatory introduction and maintaining compliance.
  • Partner with Ensera Group sites to support the development of best QA/RA practices, systems, and procedures, including the implementation of a strong Quality culture.
  • Liaise with Customers, Operations, Manufacturing, Engineering, R&D/Projects, and Sales & Marketing staff on Quality and Regulatory related matters.
  • Conduct departmental analysis to support the company goals and objectives.
  • Promoting hygiene behaviors stemming from the requirements for medical devices and medicinal products manufacturing processes.
  • Strategically identify and implement quality improvement plans aligned with Group’s objectives for QA/RA and manufacturing process.
  • Ensure all deviations, discrepancies, and investigations impacting batch disposition are adequately resolved prior to product release.

Audits & Inspections

  • Serve as a Quality Representative during customer audits and regulatory inspections.
  • Own internal audits and periodic quality system reviews.

People Leadership & Development

  • Directly supervise, train, and develop QA/RA department.
  • This role provides leadership through management of his/her staff and assigned function responsibilities as well as exerting influence on the Operations and Quality staff at the facility. He/she will lead teams including other QA/RA staff and staff from other disciplines in achieving the objectives of the assigned projects. The Director will also plan, direct, and perform training of compliance and other company staff in subject areas where he/she has expertise.
  • Ensure personnel are trained and qualified to perform assigned quality activities.
  • Coach, mentor, and teach QA/RA Team.

Cross-Functional Collaboration

  • Partner with Manufacturing, Engineering, Warehouse, and other functional teams to resolve quality issues and support compliant operations.
  • Support customer communications related to QA/RA P matters.
  • Take independent decisions regarding releasing or rejection of production batches based on established procedures, obtained test results, and own professional experience.
  • This role has the right to stop production of nonconforming products(s); and delegate responsibilities for the QMS to others in the organization.

Qualifications & Educational Requirements

  • Bachelor’s degree in a scientific, technical, or quality-related discipline (e.g., Chemistry, Biology, Engineering, Quality Management) required, advanced degree preferred.
  • Minimum 10+ years of progressive quality and hands-on experience in a regulated manufacturing environment, with demonstrated experience supporting medical devices operations, pharmaceutical, pharmaceutical packaging, PFS or Automated Injectors assembly.
  • Strong working knowledge of FDA cGMP requirements, including 21 CFR Parts 820, 210 and 211, GIF, and EMA.
  • Demonstrated experience reviewing and approving batch records, managing deviations and investigations, and leading CAPA activities in a highly regulated environment.
  • Experience with leading and hosting customer audits and regulatory inspections.
  • Strong people management experience, including training and development of quality personnel.
  • Proficient in the use of computers and standard business software, including Microsoft Office applications (Word, Excel, Outlook); experience with electronic quality management systems preferred.
  • Experienced in Good Documentation Practices (GDP) and risk-based quality principles executions.
  • Ability to read, write, and communicate effectively in English to prepare, review, and approve documentation, batch records, investigations, CAPAs, and audit responses.

Work Environment

  • This position is onsite.
  • Work is performed on the packaging floor, warehouse, cold storage warehouse, cleanroom, and office environments.
  • The role requires presence on the production floor to support quality oversight, investigations, audits, and operational activities.
  • Cleanroom gowning and personal protective equipment requirements must be followed in accordance with approved Good Manufacturing Practice (GMP) procedures.
  • Requires sitting, standing, walking, and movement between operational areas for extended periods during scheduled work hours.
  • Occasional extended hours, off-shift, and travelling support may be required to support operations, investigations, audits, or regulatory activities.