Summary of Job

The Senior Manager/Manager, GMP QA & Compliance Consultant will manage and support GMP QA consulting activities for RegDev, Inc. clients. This includes QA oversight of manufacturing, validation and testing operations at third party contractor operations. He/she will have responsibility for managing the cGMP Quality Systems function, including but not limited to change control, investigations and audits. He/she will maintain Quality Systems. In addition, he or she will manage and support GMP Inspection Readiness activities to RegDev clients.

Essential Duties and Responsibilities

Consulting Assignment may include:

• Responsible for the disposition of clinical and commercial products. Ensures appropriate quality system controls to ensure correct distribution of product.
• Manage ongoing GMP QA day to day activities associated with RegDev client’s supply of drug substance and drug products.
• Provide GMP Quality Assurance support of development activities.
• Performs batch record review, including resolution of investigations and deviations.
• Provides Quality leadership for significant deviation events or investigations at contractor sites that may impact compliance status or require regulatory notifications. Leads implementation of corrective actions and quality system improvements for RegDev GMP QA projects.
• Supports reviewing and approving CMC analytical testing documentation in support of formulation development, clinical product manufacture and commercial products, including release, stability, method validation and process validation testing.
• Conduct Internal and CMO Audits for RegDev clients.
• Review and develop GMP SOPs and Training.
• Ensures appropriate quality system implementation and oversight to ensure correct management of cGMP product.
• Manages and reviews Product Complaints program for EU and US products.
• Manage and support Quality Systems associated with production of commercial products (i.e change controls, deviations, NCMRs, OOS and product complaints).
• Writes, revises, reviews, and approves standard operation procedures and related manufacturing documents.
• Review and approve specifications and test methods.
• Partners with peers to drive the development, implementation and continuous improvement of Quality Systems, such as documentation, audits, disposition, deviations, CAPA, complaints and change controls. Ensures that appropriate site policies, SOP’s and documentation are in place to support Quality Systems according to regulatory requirements and current industry standards.

Communication of Quality Issues

• Interacts professionally with company management, internal departments, third parties and other sites to provide effective QA oversight and guidance.
• Manages complex projects effectively and efficiently through internal and external resources.

Job Requirements

Education:

• B.S.  in life sciences

Experience:

• 5-10 years in a GMP Quality function and 3-5 years of experience managing projects.
• Experience working in both commercial and development organizations.
• Experienced with new product launches.
• Experienced cGMP auditor.
• Experience with complex investigations, method development, validation and transfer.

Other Skills and Abilities:

• Strong leadership, interpersonal, communication and team building skills.
• Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate environment.
• Travel Requirement – Expectation is 10-12 domestic/N. American trips per year.
• Experience working with and managing third party vendors.
• Project management, excellent communication and team leadership skills.
• Demonstrated ability to prioritize multiple projects and meet timelines.
• A good understanding and knowledge of US and international regulatory requirements.
• Strong written and verbal communication skills.
• Independent, self-starter.

ADA Notations

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Approximately up to 30% domestic and overseas travel.
• Lifting up to 25 lbs.
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

EQUAL OPPORTUNITY EMPLOYER