JOB PURPOSE & SUMMARY OF POSITION
Perform review and release of Regulatory Starting Materials, Intermediates and Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing. Assist in the development, implementation, and maintenance of quality systems, related procedures and other Quality Assurance activities as required. Provide guidance to junior level Quality Assurance personnel.
- Across multiple projects (typically > 3 concurrent projects) provide satisfactory QA support such as review and approve master and executed batch records, deviations, OOS/OOT investigations, test method qualifications and validations, stability and Quality Control data and reports compliance to internal and GMP standards.
- Identify issues that may impact products or failures to comply with local or regulatory procedures/guidance and propose appropriate solutions to resolve issues.
- Conducts training.
- Represent the department during project meetings, client audits and FDA inspections, if needed.
- Write and revise Standard Operating Procedures (SOPs) as required.
- Provides guidance to Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
- Interacts with personnel from all departments of Johnson Matthey to ensure GMP compliance.
- Recommend and provide supporting evidence for the cessation of manufacture activities and/or distribution of product, if necessary, to QA management.
- Review master documents such as In-process forms and Batch Records.
- Approve stability study protocols, reports, and test methods.
- Assist in the scheduling and maintenance of Quality Assurance activities and systems.
- Other duties as assigned.
- Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance’s, FDA regulations, etc.
- Provides technical expertise to all departments when developing quality policies and procedures.
- Ensures site quality policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA, etc.
- Reviews all investigations and documentation to ensure compliance with Johnson Matthey’s Standard Operating Procedures (SOPs), all state and federal regulations.
- Responsible for leading efforts for audit readiness and ensuring appropriate staff are available to participate in quality audits with the FDA, other Regulatory Agencies and customers.
- Provides guidance to all departments on quality-related issues.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES
- Is knowledgeable in the understanding of all EH&S policies and procedures.
- Ensures that all job activities comply with any EH&S related rules and regulations that pertain to the department.
- Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities.
PHYSICAL DEMANDS & WORK ENVIRONMENT
- Predominately in office environment. Occasional walking, standing for long periods of time while in labs/plant, kneeling, reaching, handling, twisting, and bending spine at waist when filing or operating office/lab equipment.
- Moderate travel may be necessary for technical meetings, customer visits/audits, and supplier contacts.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
- BS in a scientific discipline or equivalent with a minimum of 3-5 years’ experience in an FDA regulated industry.
- MS in a scientific discipline or equivalent with a minimum of 1-3 years’ experience in an FDA regulated industry.
- Experience with Quality Assurance oversight and support for all phases of clinical trials and commercial API.
- Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
- Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly.
- Excellent analytical, written and verbal communication and presentation skills.
- Strong technical writing skills and the ability to clearly express ideas in English.
- Knowledge and experience with GMP, ICH Q7, and 21 CFR Part 11.
- Knowledgeable in one or more of the following areas: Quality systems, Analytical, Regulatory, Environmental monitoring, Vendor management.
- Experience mentoring and training staff members in the Quality department.
- Ability to work independently and in a team environment.
- Ability to positively resolve conflict.
- Experience with Microsoft Office and other computer software such as Trackwise, MasterControl or other EDMS.
- Flexibility for changes in work priorities.
- Actively participates in company cultural programs including but not limited to safety, quality and accountability.
- Experience with commercial phase pharmaceuticals.
- Experience with clinical phase pharmaceuticals.
- Experience with client interaction and communication.
- EMEA experience.