Director of Quality - Bloomsbury, NJ
SRG is looking for a Director of Quality for our client in Bloomsbury, NJ. This person would be responsible for managing all QA and QS departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility including operating within the legal and regulatory compliance, producing a quality product, and operating the area as the supervisor over the QA and QS staff, coordinating roles, responsibilities & projects.
Responsibilities may include:
- Supervises QA & QS managers by providing learning and development where appropriate.
- Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.
- Manages the on-time release of batches.
- Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation.
- Manages others to ensure appropriate SOPs and training documents are in place & effective.
- Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place.
- Manages others to ensure client's quality standards are met at the site so that processes are the same as other sites.
- Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
- Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
- Manages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable products.
- Manages the design and implementation of site policies and procedures.
- Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements.
- Promptly communicates with Operations regarding complaints, product issues/variances.
- Enforces applicable personnel policies and procedures
- Legally authorized to work in the job posting country
- Bachelors Degree in Life Science or other related field.
- Minimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industry.
- Minimum 5 years of supervisory or management experience required.
- Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products.
- Technical writing and communication.
- Well versed in the compliance & quality requirements of 503B pharmaceutical industry and cGMPs and have demonstrated strength in problem solving and resolution.
- Strong interpersonal skills
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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