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Manager Quality Assurance

  • Job reference: 926455
  • Location: North Holland
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 09/07/2019

We are currently recruiting for a Manager Quality Assurance role on behalf of our international Client located in the Netherlands.

In this position, you will be responsible for the Commercial Quality Release activities in Quality Center NL in alignment with business unit, in order to ensure products are efficiently distributed into the Netherlands and other European countries, including the release of clinical supplies by meeting regional and local standards and customer needs.

Duties & Responsibilities:

Local Quality System deployment :

  • Ensure GMP &GDP compliance at the commercial unit and promote quality culture
  • Ensure GMP and GDP training at a local level
  • Initiate continuous improvement of processes
  • Lead Local Cross functional Quality Council
  • Attend to European monthly quality councils
  • Provide the relevant data to the European Commercial Quality local monthly quality metrics

Operational implementation Quality Management System (QMS):

Market release

  • Ensure market release from approved suppliers based on batch release documentation and transport conditions documentation
  • QP certification
  • Ensure QP batch certification according to GMP Annex 16 for products including clinical supplies as service for R&D, for NL market as well as European countries

Distribution

  • Ensure GDP compliance of the distribution center(s)
  • Approving returns to saleable stock and ensuring the distribution traceability of finished products and returns of products commercialized in the country
  • Deciding on final disposition of rejected, recalled or falsified products

Complaints and Recalls

  • Administer, maintain and develop systems for change control, deviation and CAPA handling
  • Suppliers/customers and 3rd party service providers
  • Maintain and monitor a list of approved suppliers/customers/providers
  • Ensure Quality Agreements are drawn up and kept updated with all local suppliers/customers and 3rd party service providers as required

Subcontracting

  • Approving any GDP subcontracting activity
  • Archiving
  • Ensure relevant quality related documentation is archived as required
  • Critical Quality Incidents:
  • Escalate to sub-Regional Commercial Quality Head critical quality issues raised at local level
  • Ensure local deployment of action plan related to quality incidents
  • Ensure appropriate communication with local Competent authorities
  • Define inspection CAPA plan and submit it for approval to Sub Regional Commercial Quality Head
  • Ensure inspection CAPA plan defined is deployed in due date
  • Ensure self-inspection is performed at regular intervals

Business support:

  • Establish network in the country with direct and indirect reports
  • Participate in periodic local management meetings organized with other supportive functions (Supply chain, Regulatory Affairs, Pharmacovigilance…)
  • Regular meetings with local General Manager of Commercial Units to align quality objectives with business objectives and local strategic plans
  • Managerial tasks:
  • Manage and lead Commercial Quality Units team members
  • Train and provide professional guidance to teams
  • Define annual objectives in compliance with annual Sub-Regional Commercial Quality objectives
  • Perform annual processes such as performance reviews, compensation, etc., taking into account local business partners input
  • Participate in the annual budget elaboration
  • Lead periodic face to face meeting with CQU team members and lead periodic local CQU meetings
  • Define a delegate as back up
  • Assure the execution of sub-regional projects coordinated in the country, as applicable
  • Support Sub-Regional/Regional Quality initiatives outside the country as needed

Education Required:

Master´s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role

Education Preferred:

  • Post-graduate or Doctoral degree in Pharmacy, Medicines, Biology or similarly related fields of specialization

Experience required:

Minimum of 2-year experience as a Quality Manager/QP in a pharmaceutical company or importer/distributor

Experience Preferred:

Minimum of 4-year experience as a Quality Manager/QP in a pharmaceutical company or importer/distributor

Specialized or Technical Knowledge Licenses, Certifications needed:

  • Demonstrated knowledge and working experience with government regulations for the country
  • In-depth knowledge of the pharmaceutical industry as it relates to Quality Compliance
  • Working knowledge of pharmaceutical operations.
  • In-depth understanding of cGMP & GxP's regulations
  • Experience with development and implementation of Quality Systems and application of risk assessment tools
  • Proficient computer skills in current software including MS Office
  • Excellent English

Skills & Competencies:

  • Technical & Professional Expertise:
  • Result-driven
  • Determine stakeholders needs and expectations
  • Ability to adhere determined timelines
  • Problem Solving
  • Gather and assess relevant information, using abstract ideas to interpret it effectively
  • Open minded, out of the box thinking, creative thinking to create the most efficient solutions
  • Autonomy & Independence
  • Demonstrate initiative and creates an appropriate level of urgency to meet objectives and deadlines
  • Able to learn independently and quickly
  • Adaptability and stress tolerant; organized, execute with the ability to be agile and flexible even under adverse circumstances
  • Understand when a problem needs to be escalated
  • Communication, Collaboration & influencing
  • Team Player with strong interpersonal skills
  • Actively collaborate and cooperate with others
  • Establish and maintain strong professional relationships at all levels within the organization
  • Proven ability to work within a team and influence people outside areas of authority to achieve results
  • Demonstrate good oral and written skills
  • Good Presentation skills


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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