Seqens is an integrated billion-dollar global leader in pharmaceutical synthesis and specialty ingredients. Seqens Innovative & Generic Pharmaceuticals (IGP) division provides biotech and pharmaceutical companies with the expertise and capacity needed to develop and manufacture complex small molecules including active pharmaceutical ingredients (APIs), intermediates and drug delivery solutions, whether at research, development or commercial scale.  The company also has extensive expertise in medical-grade polymer synthesis, flow chemistry, bio-catalysis and highly potent APIs. Seqens offers tailor-made solutions to sponsors for all their needs.

Based in Boston, Mass., Seqens IGP division, North America operates a cGMP facility, where its R&D and kilo labs are fully integrated with commercial manufacturing capabilities of up to 2000 gallons. The company is able to offer unique local presence, but global industrial and quality & regulatory resources in Europe, North America and Asia.

Purpose of the position:
To supervise Quality operation activities and ensure that the quality assurance/management system complies with the Current Good Manufacturing Practices (cGMP), ISO 9001 and registration files. Promotes quality culture at site level.                              

Main missions:
·         Provide effective, ‘hands-on’ leadership to the QA operation team

·         Assist Change Control owners with ensuring compliance to change procedure requirements, assesses and approves changes related to processes and products, ensure appropriate implementation of changes and CAPA actions

·         Conduct GMP document review, including procedures, work instructions, methods validation data/reports, protocols, and new Batch Records

·         Provide annual GMP training

·         Manage review and approval of the executed batch production, analytical control records, equipment cleaning records, specification and stability data and protocol

·         Manage release or rejection of raw materials, intermediates, packaging, and labelling materials

·         Manage release of APIs for distribution

·         Conducts quality investigations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations, OOS and customer complaint

·         Approve procedures impacting the quality of intermediates or finished products

·         Participate in interna/external audits, self-inspection, and regulatory inspections

·         Supervise the product quality review

·         Maintain Quality Metrics to support process improvement activities

·         Identify, facilitate, and/or lead continuous improvement efforts

·         Identify and communicate risks and assist with risk mitigation plans as necessary

·         Provide support for regulatory filings

·         Ensure qualification of the team, consistent with SOP, to support cGMP activities

·         Provide weekly update of team activities and assigned projects to Site Quality Director

·         Participate in Quality Management review

·         To support validation and qualification protocol review, troubleshooting and final approval

·         Assist in customer complaint investigation, as required  

Each employee contributes, in exercising his functions, to the efforts and commitments of the group in terms of Quality, Hygiene, Safety and Environment.

The manager/employee must develop, apply and make apply in his team:

ü  The Safety policy, the Safety procedures and the Safety behavior in general,

ü  The Environment policy, the Environment procedures and the Environment behavior in general,

ü  The Quality policy, the Quality procedures and the Quality behavior in general.

Education
B.Sc. A bachelor’s degree in a life science or engineering
Professional experience
-       A 8-10 years’ experience in related Pharmaceutical Quality/GMP roles, including a minimum of 3 years’ direct experience in batch record review, product release, deviation/investigation and/or CAPA systems, including providing KPIs, metrics, trend reports.

-       Expertise in Change Control the impact assessment, and CAPA.

-       A working knowledge of cGMP regulations used to produce API

-       Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections

-       Ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
Human skills and values
Ability to organize and manage a plan

Coaching and knowledge transfer competences

Strong GMP mindset

Decision support
Others
Great communication skills 

Build relationships