Associate Director Quality Assurance

Recruiter
Edelway
Location
Netherlands
Salary
Competitive
Posted
16 Jun 2017
Closes
23 Jun 2017
Job Title
Director
Contract Type
Permanent
Hours
Full Time

We are now looking for an Associate Director Quality Assurance to join a global pharmaceutical client in the Netherlands.

THE ROLE:
The Associate Director Quality Assurance will act as the EU/EEA Qualified Person in accordance with EU GMP to provide final certification/release of the client's clinical and commercial pharmaceutical products along with Quality Assurance and Regulatory support. While based at the client's Netherlands office, the role will also include responsibilities for the Quality oversight of commercial product distribution in Europe. The Associate Director Quality Assurance is a member of the International Quality Assurance team.

YOU WILL:

*Day to day batch release and certification of commercial product in the EU to ensure the batch and its manufacture comply with the GMP and provisions of the marketing authorizations;
*Day to day batch release and certification of IMP destined to European clinical trials to ensure the batch and its manufacture comply with the GMP, product specification file and clinical trial applications;
*Maintenance of a Batch Register;
*Providing QP GMP declarations in support of importation and regulatory activities;
*Ensuring that the principal manufacturing and testing processes have been validated;
*QP review and evaluation of deviation, complaints, change controls and PQRs;
*Performing QP audits;
*Establishing QP to QP agreements when required;
*Commercial product distribution oversight;
*Establishment and maintenance of the client's Netherlands QMS and ensure a state of inspection readiness;
*Interact with the local Dutch Authorities as it pertains to the client's Netherlands Licenses and GMP/GDP activities;
*Ensure that the pharmaceutical quality of the marketed product is maintained during distribution and in accordance with EU GDP;
*Qualification (including audits and Quality Agreements) and Quality oversight of distribution contractors;
*Recall coordination of medicinal products when needed;
*Review Change Controls, Deviations, Investigations and CAPAs as it pertains to distribution of product;
*Manage relevant customer complaints to resolution;
*Decide on the final disposition of returned, recalled or falsified products;
*Perform GDP risk assessments;
*Maintain knowledge of current guidelines and GMPs/GDPs in line with duty for continual professional development and to establish a regulatory compliance watch;
*Interface: Supply Chain, CMO QPs, distribution partners and contractors and RA-CMC.

YOUR PROFILE:

*Fully qualified QP with experience of final certification/release within the EU/EEA;
*A good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations would be advantageous;
*Strong EU regulatory understanding;
*Graduate, preferably in Chemistry, Pharmacy or Biological Science;
*Wide ranging technical knowledge and experience within the pharmaceutical industry;
*Substantial previous Quality Assurance experience;
*Excellent scientific and technical knowledge;
*Multi-skilled across several areas and has developed specialist expertise relevant to function;
*Up to date knowledge of cGMP, cGDP and regulatory expectations;
*Team player and ability to work with remote teams;
*Travel up to 30%;
*English fluency written and spoken;
*Strong verbal and written communication skills with well-structured communication and presentation ability;
*Strong interpersonal skills.