Quality Manager is an independent self-starter, with strong understanding and experience in regulatory Quality Systems who has a strong adaptability to navigate changing regulatory requirements and business priorities. Quality Manager is responsible for direction and coordination of all Quality System activities for SteriPack USA Limited. This position is responsible for compliance of the Quality Management System, including the support of any SteriPack Global requirements, applicable Regulatory standards, and Customer requirements.

Duties & responsibilities

The successful candidate will be responsible for:

  • Implementation and maintenance of effective Quality Assurance System in accordance with the requirements of cGMPs. ICH guidelines, and other relevant pharma regulatory requirements.
  • Drive adherence by supporting all internal and external quality and regulatory requirements.
  • Ensuring that processes needed for the Quality Management System are adequately documented and followed.
  • Reporting to top management on the effectiveness of the Quality Management System and any need for improvement.
  • Establish quality team and individual goals and objectives in alignment with customer-focused team goals and customer requirements.
  • Be a key contact and local subject-matter expert for QMS system elements (e.g. complaint investigations, change control, deviation, CAPA,etc.).
  • Ensuring the support and promotion of awareness of applicable regulatory requirements and Quality Management System requirements throughout the organization.
  • Ensuring that QMS documents are regularly reviewed and up to date.
  • 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 SteriPack Group sites to support the development of best QA 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 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 process.

Qualifications, education & skills required

  • Bachelor’s degree in engineering, science, healthcare, or related fields preferred and minimum 10+ years of proven Quality experience in a regulated environment with in-depth knowledge of pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
  • Strong analytical ability to review technical data.
  • Strong computer capability, to include Word, Email, Excel, PowerPoint, and other Microsoft based programs.
  • Strong technical skills in Quality Management, Systems and Regulatory standards, e.g. relevant training.
  • Fluency in written and spoken English.
  • Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.

Work environment

  • Indoors office and Cleanroom.
  • Requires standing, walking, sitting throughout the day.
  • Must be able to travel up to 10% of the time.

Scope of position

  • Take independent decision regarding releasing or rejection of production batches based on established procedures, obtained testing results, and own professional experience.
  • Take independent decision regarding releasing or rejection of raw materials and packaging materials for manufacturing process.
  • Take independent decision regarding obtained testing results for medicinal products.
  • Has the right to stop production of nonconforming product(s).
  • Access to full information and documentation related to the manufacture of medicinal products.
  • Access to all areas connected with the manufacturing process of the medicinal products.
  • Represent the company to external institutions, including the support of submission of applications for registrations.
  • Has a right to delegate responsibilities for the QMS to others in the organization.
  • Has a right to approve:
    • All the documents coming out from QMS with exception of Quality Policy.
    • Quality Agreements
    • Certificates of Conformity
    • Certificates of Analysis
    • Internal regulations
    • Official applications
  • Participate in the recruitment of staff to quality and supporting departments.
  • Participation in the creation of budgetary planning
  • Access to the professional press and training materials existing in the company.
  • Access to the resources needed to perform their tasks and to represent the company in accordance with its image.
  • Has the right to submit proposals to manager that are required to accomplish the aforementioned tasks.

Join us in our mission to make a positive impact on healthcare through innovation and excellence in manufacturing. If you are a motivated professional with a passion for bid management and a desire to thrive in a dynamic and rewarding environment, we want to hear from you!