QA Project Manager – 6686 (ADA)
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a
QA Project Manager
for a
maternity cover of 8 months
, based out of
Visp, Switzerland
.
Main Responsibilities:
* The Manager of this department is responsible for providing daily oversight, tactical and strategic leadership for a team of QA Project Managers directly supporting the internal and external customers.
* Key management deliverables are to provide general leadership, guidance and support to ensure QA Project Managers are providing internal and external customers, with quality support for the following: Quality deliverables (e.g. sterility assurance assessments) are met for key milestones during tech transfer (TT) and process validation, material assessments, issues related to tech transfer are addressed and brought to resolution, process validation execution, TT production issues, deviations, change controls, regulatory compliance issues, quality agreements, and mange and track key Performance Indicator metrics for internal and external customers.
* Ensure staff is meeting QA objectives and deliverables on time and in-full compliance, perform key functions and support overflow of tasks needed to ensure deliverables are met.
* The manager trains the team and leads them in the identification, defense, and resolution of Quality issues with necessary decision making and supporting documentation.
* The manager leads the process of weighing the risk of the events and search for effective, efficient, and compliant solutions.
* Provide general direction, support and act as a point of escalation for QA staff and customers.
* Ensure QA objectives are delivered on-time and in-full to internal and external customers while aligning with respective Quality Agreements, SOPs and Regulations.
* Develop team goals and ensure continuous improvement, team efficiencies, innovative thinking, track progress and implementation. Oversee training, mentor, and develop in Quality principles.
* Conduct objective setting and regularly scheduled sessions with individuals of team to review objectives, provide feedback and provide guidance for personnel advancement.
* Act as QA Project Manager for a client project when required.
* Interview & hire personnel to provide responsible, experienced people to carry out job function.
* Partner with internal customers for all Change Controls, Deviations, CAPAs, and Investigation review serving as the Quality Subject Matter Expert.
* Supporting the site as senior QA on higher risk change controls and Deviations from the areas of MSAT, Engineering, QC, Validation, SC, and Manufacturing.
* Attend meetings prepared to speak to the project/change and identify Quality requirements.
* Support completion of QA deliverables associated with lot disposition, change controls and root cause analysis on deviations.
* Manage and track Key Performance Indicator Quality metrics and attend other meetings- represent department at site meetings.
* Prepare deviation trending reports for Senior site management, assess trends and provide recommendations.
* Support Regulatory and Customer Audits as needed.
Qualifications and Experience:
* Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
* Bachelors or master's degree in Science, Biotechnology or related discipline
* 10 plus years of experience in Quality Assurance area
* 10 plus years of experience of managing direct reports
* Excellent communication skills in English