SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

The Senior Manager, Quality Assurance CDMO will work closely with the General Manager, CDMO to oversee the implementation of the new laboratories and GMP manufacturing facilities to meet the required regulatory standards that are phase and dosage appropriate. The successful individual will be expected to be equally skilled at managing people, building a QA team and understanding processes in the lab, demonstrating a clear grasp of the commercial realities of a contract research environment, and managing the detail to ensure timely results, data efficacy, and a seamless audit trail.

Additionally, they will drive day-to-day QA requirements for site readiness, the role will be involved in positioning projects with customers during the Business Development process as well as being involved in the actual project delivery ensuring that quality requirements are met as required by regulators and customers.

• Ensuring that the QA department is integrated into project delivery from project initiation to completion
• The individual will need to ensure that prioritizing, allocating, and monitoring work across team members to meet customer deadlines is managed appropriately
• Working closely with the Project Manager to ensure that plans and resources are aligned to meet customer needs in an accurate manner
• Achieve throughput and turnaround targets on a project, monthly and annual basis, monitoring and reporting on the productivity of the team
• Report performance against Key Performance Indicators (KPIs)
• Ensure that the Quality systems are organized and maintained to meet both customer and regulatory requirements
• Establish excellent communication systems including regular meetings within the QA team and across departments to ensure customers’ needs are achieved and quality systems are being followed correctly
• Engage and involve all departments with the updating and implementation of new quality procedures and systems
• Develop a collaborative, pragmatic culture that encourages colleagues to support each other in problem-solving to achieve excellent and timely results for customers
• Responsible for the quality of work within the QA team and proactively striving for improvements
• Ensure that work conducted across the business complies with the requirements and standards of the accrediting bodies
• Ensure that all staff comply with appropriate quality systems and work with the other departments to ensure that staff is properly trained
• Managing internal and external, contract QPs for appropriate support across projects

• Bachelor's degree in a related science field
• 7+ years of relevant work experience
• 3+ years previous supervisory experience preferred
• Previous QA management experience from a pharmaceutical contract service environment with exposure to IMP’s and non-sterile development and manufacture
• Strong QA background with good operational understanding
• Experience in a commercially focused environment with tight deadlines and constantly shifting priorities
• LIMS exposure and implementation of such systems would be desirable
• Master's degree or higher in a related science field is preferred

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

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