QA for QC Senior Specialist

at  WuXi Biologics

QA FOR QC SENIOR SPECIALIST

Reporting to the QA DS MFG Lead/QP, the Senior Quality Specialist (QA for QC) will play a key role in supporting the QC function to ensure the highest standards of professional excellence and quality assurance within the business. With responsibility for supporting the Pharmaceutical Quality System (PQS), adhering to all regulatory, cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of Quality.
Organization Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world’s top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

DEPARTMENT DESCRIPTION

As Senior QA for QC Specialist, you’ll join an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the QA DS MFG Lead/QP.

EDUCATION

• Degree qualification in biopharmaceutical science or related discipline.

KNOWLEDGE/EXPERIENCE

• 8 years plus work experience in GMP chemical or microbial Quality Control with a well-rounded exposure to all areas in this field, preferably in the Biopharma/pharmaceutical industry.
• Experience in generation, review and approval of quality documentation as required i.e. SOPs, CoA’s, specification documents, protocols, reports etc.
• Ideally, experienced in establishing a QA/QC team in a ‘greenfield’ context of similar size and scale.
• Ability to conduct audits for QC area, to support our culture of compliance and to meet regulatory, market, EU, FDA, and company standards.
• Expertise in the release of GMP materials and participant in QC activities, such as method transfer, validation.
• Knowledge and proven experience in implementing investigational tools, root cause analysis and driving closure of investigations.

PERSONAL SKILLS

Required:

• Strong leadership competencies with demonstrated management skills.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Self-starter and self-motivated; organized with good attention to detail.
• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• Collaborative and inclusive approach to work and your colleagues.
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectation.

• Lead QA support for site start up, technical transfer and routine operations within QC department.
• Develop/build a world-class Biologics QA for QC Specialist team including planning, recruiting/hiring, coaching/mentoring, and training for a headcount of approximately 1-3 people.
• Lead the development, implementation, and maintenance of the local Pharmaceutical Quality System (PQS).
• Participate and lead as necessary, deviations, CAPA’s, change controls, suspect analytical result investigations, laboratory, and site investigations.
• Oversee the preparation of reports such as the Annual Product Quality report.
• Liaise with relevant departments to ensure timely closure of quality actions.
• Drive the continued development of the Pharmaceutical Quality System (PQS) by constructively challenging deficiencies and inefficiencies.
• Assist and participate in audits as required, including self-inspection audits, regulatory audits, and customer audits.
• Collaborate internally and also across the WuXi network to achieve quality goals.
• Lead the development/implementation of continuous improvement activities.
• Closely monitor the construction quality of QC lab, review CSQ documents and participant FAT as required.
• Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective.
• Responsible for the release of GMP materials and participant in QC activities, such as method transfer, validation etc.
• Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
• Flexibility to take on additional tasks and responsibilities at the discretion of the QMS Lead/QP.