We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.

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.

Your responsibilities:

• 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

Essential

• 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.

Valued

• Experience with commercial phase pharmaceuticals.
• Experience with clinical phase pharmaceuticals.
• Experience with client interaction and communication.
• EMEA experience.

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

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