Global Quality Manager Distribution – Hollister – Roosendaal

Hollister

We Make Life More Rewarding and Dignified 

Location: Ballina 
Department: Quality 

Summary:

This role is part of the Quality Operations Leadership Team and has responsibility for Quality activities across the distribution organization. The role will partner with Operations, Supply Chain & Global Contract Manufacturing to ensure the on-time delivery of high-quality products to our End Users.

This role requires strong experience working in a quality organization in particular as it relates to the supply and distribution of medical devices and the management of contract manufactured product.

The role can be located out of one of our European locations, including Roosendaal, Netherlands; Ballina, Ireland; and Kaunas, Lithuania.

Hollister Incorporated operates in a hybrid environment. A minimum of 3 days per week in the office is required.

Responsibilities:

Day to day responsibilities include but are not limited to the following:

  • Responsible for ensuring that finished product is transported, stored and delivered in accordance with Good Distribution Practice (GDP) and that the company is meeting the requirements as outlined in the medical device regulations.
  • Ensuring that any deviations are identified, documented, and investigated, and that corrective actions are taken to prevent a recurrence.
  • Ensuring that the quality management system is in place and that it complies with relevant regulations.
  • Directly lead the Global QA teams involved in Supply Chain.
  • Collaborate with Operations, Distribution, Supply Chain, Contract Manufacturing, 3rd party manufacturers and the broader Quality organization Managers to ensure achievement of existing quality levels and seek methods to continually improve quality outcomes including leading on cost of quality and standardization initiatives.
  • Develop and advise on the continuous improvement of quality system processes and procedures.
  • Build and deliver effective communications at all levels while displaying active listening skills.
  • Provide leadership in change management.
  • Provide QA technical direction and guidance to achieve company objectives.
  • Support the preparation and management of the QA operating budget in conjunction with the Facility Managers.
  • Provide oversight for Distribution complaints/ SCARs
  • Provide guidance for all distribution providers e.g. 3PL and 4PL
  • Provide direction & quality oversight for projects linked with Distribution.
  • Other duties as required.
  • Strategic Leadership:

  • Develop strategies, tactics, and actions for Supply Chain to support corporate & functional objectives and to ensure that all parties within the supply chain network are meeting the requirements of the Quality management System to ensure the safety, quality and performance of finish products.
  • Partner with internal business partners to bring innovative, efficient and cost-effective solutions.
  • In conjunction with other Quality Leaders, execute on overall Global Quality Strategy ensuring alignment with key stakeholders.
  • Drive business results (service levels, inventory targets, financial targets, and annual cost reductions), as well as oversee management of daily operations.
  • General:

  • Set near-term and long-term goals and performance objectives (KPIs) and define initiatives to support these and overall business objectives.
  • Hire, coach and develop team for high performance; Assess, assign/realign job duties as needed; Ensure succession plans are in place.
  • Assess performance data to identify, justify and execute strategic and process-oriented projects in collaboration with stakeholders and business partners.
  • Build relationships with key stakeholders and business partners to achieve optimal information flow and product flow and to ensure alignment on vision, priorities, initiatives, etc.
  • Active participation at various corporate wide and department specific meetings, including staff meetings, team meetings.
  • Ensure compliance with corporate and/or industry initiatives particularly in areas of Regulatory Compliance and Environmental, Social, & Governance (ESG).
  • Essential Functions of the Role:

  • Located in one of our European Hollister manufacturing or distribution center locations.
  • Ability to travel to US and international locations as required and working across time zones.
  • Cross-functionally collaborate in a matrixed organization.
  • Utilize the Company Continuous Improvement Process.
  • Set a positive example related to quality, safety & service.
  • Communicate with excellent written and verbal skills.
  • Leverage strong critical thinking and problem-solving skills.
  • Employ strong change management skills.
  • Number of Overall Years Necessary: 8-12
  • Preferred type of experience:

  • Supply Chain, Distribution & Supplier Quality Management
  • Quality Assurance & Quality Control incl. CAPA, non-conformance management, complaint management, audit management (internal & external), validation.
  • Proficiency in EUMDR, ISO13485, GDP
  • Continuous Improvement
  • Work Experience Requirements:

    Preferred length of experience:

  • Minimum of 6 years in a Medical Device or Pharma Regulated industry
  • Minimum of 4 years in supervision role leading teams
  • Education Requirements:

  • Minimum of a bachelor’s degree in science, Engineering, or related discipline
  • Masters’ degree in related field is preferred.
  • Specialized Skills/Technical Knowledge:

  • Skilled in developing and maintaining relationships with Internal Business Partners, Suppliers/ Contract Manufacturers
  • Working knowledge of manufacturing processes, quality systems, and regulatory requirements
  • Experience working with multi-cultural teams
  • Skilled at managing projects
  • Working Knowledge of 21 CFR 820, ISO 13485:2016, EU MDR regulation at a minimum
  • Black Belt/Green belt certification an advantage with strong knowledge of Lean and Six Sigma methodology preferred.
  • Knowledge of SAP/S-4 Hanna systems preferred.
  • Technical knowledge, including a good understanding of GDP regulations, medical device quality systems and supply chain management.
  • Behavioural skills, such as leadership and communication, to manage team effectively.
  • Local Specifications:

  • Must be fluent in verbal and written English
  • About Hollister Incorporated

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