QA Director - Internal QA team

We are currently looking for a strong QA Director to lead the internal quality group. This is a newly created position and a critical role, that will work closely with Senior Quality director and QP and the Vice President of Quality and Regulatory Affair.

About the job

The QA Director, internal QA team will be managing a team of 5 QA specialists and 1 QA chemist. To do this successfully, it is expected that the right candidate already has a solid experience within QA for a manufacturing facility.

The position will manage the internal QA group and contribute directly to problems solving and document writing. 

Responsibilities in QA

Be direct responsible for the activities which are carried out by the team. Activities like timely handling of:

• Review and preparation of batches (API and DP) for QP batch release
• Assure handling of deviations, CAPA, changes and complaints
• Root cause investigation
• Approval of validation/qualification activities
• Writing and review of PQRs
• Assure reporting of monthly KPIs
• Leverage of critical topics to both VP Quality and QP
• Be able to handle and lead own root cause investigation regarding OOS investigations and manufacturing investigations
• Support to other departments in relation to GMP/GDP projects and supply launch activities, like improvements of facilities, utilities or production equipment, new serialization requirements etc...
• Optimization of QA processes and helping production in optimization projects
• Audit skills
• Support QP in authority inspections and customer and partner audits
• Annual GMP Training

About you

Educational requirements / Qualifications

• Cand. Pharm, Cand. Scient, Chemical Engineer or other relevant background
• At least 10 years' experience as a QA chemist/scientist supporting DS and FP manufacturing.
• Experience with QA activities related to a manufacturing site
• Experience with auditing and self-inspections
• Experience with root cause investigation and risk assessments 

Skills / Competencies

• Must possess strong analytical and problem-solving capabilities
• Ability to interpret data and communicate to key stakeholders to assist with decision making
• Strong written and verbal communication skills
• Ability to discuss technical issues at the plant staff level as well as with a group of technical peers
• Drive, be proactive and highly motivated
• Management capabilities

What Pharmacosmos offer

• An opportunity to manage a new team of QA specialists and be part of a dedicated QA team
• Possibility to influence the continued development of the position and the area
• Possibility to impact a growing organization with big development potential
• Many development opportunities alongside with attractive benefits

Contact

For further information do reach out to Jens Knud Maarup on telephone +45 5433 4320 or jens.maarup@pharmarelations.dk. Due to GDPR, we cannot receive any CVs via e-mail.