Senior Consultant, Quality Assurance
Title: Senior Consultant, Quality Assurance
Area of Focus: CMC
FLSA Status: Independent Agent (1099)
Essential Duties and Responsibilities
- Directs quality assurance functions necessary to support production of biologic products at contract manufacturing organizations for clinical testing.
- Directs Quality Assurance Operations functions associated with IND and New Product Development activities.
- Conducts quality audits, including writing audit plans and reports.Oversees vendors’ responses to audit observations and implementation of CAPAs.
- Establishes quality system for client companies.Identifies necessary documents and drafts SOPs.Works closely with the client and contract manufacturing organizations (CMOs) to assure GMP-compliant, and timely delivery of client objectives/projects. Works with technical team to translate research projects into manufacturable products.
- Drafts CMC sections of regulatory filings including INDs and IMPDs. Responsible to assist in the creation of CMC documents for IND filings to meet Global Quality standards and applicable regulatory requirements.
- Leads quality group to collaboratively address GMP compliance concerns and/or needs. Directs QA colleagues to ensure that tasks are completed to meet client needs in the agreed upon time frame.
- Recognizes risk and proposes contingency plans. Assumes GMP compliance responsibility for projects. Collaborates with regulatory colleagues and may interact with regulatory agencies including, but not limited to FDA, EMA, Health Canada. Directs investigations of manufactured product to assure appropriateness and completeness of required documentation.
- B.S., M.S. or PhD in biology or a related science combined with 10 years’ experience in Drug Product and Drug Substance quality systems for pharmaceutical manufacturing and validation.
- Demonstrated leadership including five years management experience, preferably dealing with biologicals.
- Strong knowledge of Sterile Drug manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing.
- Excellent understanding of FDA, EU, and ICH cGMP guidelines and industry best practice, with demonstrated ability to apply these to drug substance and drug product operations.
- Sound judgment, analytical, problem-solving and decision-making skills.
- Ability to handle multiple assignments and changing priorities along with fluctuations in work load.
- Demonstrated planning, project management, negotiation, facilitation and presentation skills. Project management certification a strong plus.
- Ability to work both independently and collaboratively in a team structure. Uses a team-oriented approach to project management and problem resolution. Holds self and others accountable in achieving collective goals.
- Excellent verbal and written communication skills, including the ability to generate SOPs and regulatory documents.
- Proficiency with Microsoft Project, Word, Excel and PowerPoint required.