Senior Quality Manager

ZipRecruiter; Lancaster; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading company in the nutritional supplement sector is seeking a Senior Quality Manager to develop and deploy quality systems, ensure compliance with regulatory standards, and collaborate across departments. Candidates must have a BS in a relevant scientific field and at least 10 years of experience in quality assurance within the industry.

Qualifications

• Minimum 10 years of experience in quality control and assurance in nutritional supplement or pharmaceutical manufacturing.
• Laboratory management experience required.
• Strong understanding of industry regulations, FDA, USP, AOAC, and ICH guidelines.

Responsibilities

• Ensure quality compliance for manufacturing and packaging processes.
• Lead internal and external audits related to quality.
• Develop and deploy quality systems for product conformity.

Skills

Quality control testing

Problem-solving

Interpersonal skills

Team-building

Education

BS in Chemistry, Microbiology, or related Science field

Job description

Summary of the Position: Develops and deploys the quality system for manufacturing facilities and must have a good understanding of laboratory practices to ensure systems and procedures are compliant with government regulations, industry standards, and company policies. Responsible for collaborating with other quality managers and operations management to align material handling, equipment cleaning, and room cleaning with process flows in manufacturing and packaging operations within Nutramax as well as CMOs.

Roles and Responsibilities:

1. The SQM must have a strong understanding of GMP requirements and regulations related to dietary supplements manufacturing and preventive controls for animal food (21 CFR Part 111 and 21 CFR Part 507).
2. Ensure quality processes related to manufacturing and packaging, including all cleaning procedures across facilities.
3. Work closely with operations management to ensure work instructions are appropriate for different work centers.
4. Align batch records with work instructions/OJT and oversee in-process quality checks in all product manufacturing areas such as tableting, encapsulation, powders, liquid filling, soft chews, pellets, etc.
5. Establish standards where necessary.
6. Collaborate with the supply chain to manage raw materials release and availability for manufacturing.
7. Lead internal and external audits related to the microbiology laboratory and develop strategies to address audit findings.
8. Oversee all product or situation investigations relevant to manufacturing operations.
9. May act as the Management Representative for Quality when necessary.
10. Develop and deploy quality systems (e.g., CAPA, design control, process control) to ensure product conformity.
11. Manage teams during regulatory inspections.
12. Ensure quality compliance for contract manufacturers.
13. Communicate effectively across departments and work within a team environment.
14. Maintain regular attendance.
15. Perform other duties as required to meet company objectives.

Minimum Requirements:

• Strong understanding of quality control testing and assurance processes.
• Thorough knowledge of industry regulations, FDA, USP, AOAC, and ICH guidelines; experience with pharmaceutical and nutritional supplement GLP/GMP compliance is preferred.
• Effective interpersonal skills and ability to interact at all levels.
• Problem-solving skills.
• Excellent motivation and cross-functional team-building skills.

Education and Experience: BS in Chemistry, Microbiology, or related Science field; minimum of 10 years’ experience in quality control and assurance within the nutritional supplement and/or pharmaceutical manufacturing industry. Laboratory management experience is required.

Supervisory Responsibilities: Yes – managing quality staff.

• Enforce safe work practices and procedures.
• Correct unsafe conditions promptly.
• Train employees to identify and report hazards.
• Handle incident reporting and investigations, including coordination with EHS and emergency response teams.