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Search for Jobs by Sheryl Horowitz

Quality Assurance Manager (Science & Biotech)
Durham, NC 27703
Recruited by: Sheryl Horowitz | Recruiter | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Aug 20, 2021
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Job Description

Our client, a global pharmaceutical company and terrific team, is now hiring!

Overall Purpose:

The QA manager is a critical member of the RTP Quality management team and provides QA support and ongoing direct oversight of all GMP related activities the RTP facility. The role is a key contact point and quality representative which provides Quality Assurance (QA) support and oversight for critical API, finished drug product, component, and drug delivery system manufacturing/testing operations at contract facilities globally for development and commercial products. The role ensures that all quality-related issues are effectively communicated and managed between management and the contract manufacturers and laboratories.

Essential Duties & Responsibilities:

Primary Responsibilities
Develop, implement, deploy, and maintain adequate and compliant quality systems, procedures and processes which support the commercial and development products and business objectives of the company and at the RTP site specifically.
Oversees and manages the day-to-day execution of QA operations which support GMP manufacturing and laboratory testing activities occurring at the RTP facility. Partners with Science and Technology teams for Implant Manufacturing and Manufacturing and Analytical teams to support commercial and development drug products.
Manages the Global Supplier Management Program and associated procedures and processes; including maintaining audit schedules and approved supplier lists; tracking, reviewing, and responding to supplier out-of-specification results, failure investigations, deviations, and change controls (equipment and document); participating in supplier audits; develops and deploys metrics and provides periodic updates on the Supplier Management program to site and executive management.
Supports the Product Quality Complaint (PQC) program; ensuring returned complaint units are received, inspected based on specific complaint type and provide inspection summary into the respective complaint record. Additionally, ensures complaints are investigated and closed in a timely manner and supports the operation of the product quality complaint procedures and systems as required.

Review and approval of quality-related documents affecting company products, including but not limited to: protocols/reports; qualification, validation, process and analytical method transfers and stability protocols and reports; analytical and qualification test results, including raw data; change controls, deviations, and laboratory investigations.

Represents QA on various development, manufacturing, and continuous improvement. Works directly with QA groups at contract manufacturing (CMO) and test (CTL) project teams. Applies a phase appropriate GxP approach to quality and compliance when working with internal groups (Science and Technology, Manufacturing, Chemistry, Analytical, Regulatory, Clinical) during development to commercial activities to ensure both compliance and project timelines are maintained.
Reviews and release executed GMP manufacturing batch records for compliance to manufacturing processes/steps, ensuring that all applicable documents, records, and forms are completed and attached.
Development of controlled documents and procedures pertinent to QA activities and functions, as well as other procedures as deemed necessary.

Other Responsibilities
Review CMC and other documents in preparation for Regulatory submissions, including IND, NDA, and Annual reports.
Support the development, implementation, and maintenance of quality systems including, but not limited to: Supplier Management, Qualification/Validation, Distribution, Investigational product labelling and packaging, and Combination product requirements.
Supports regulatory inspections as the process owner for API and drug product and drug product delivery systems release and supplier management.
Conducts GMP training and supports the execution of training across the RTP site.
Act as back-up to Director, Quality during regulatory inspections.

Additional Dimensions:

Travel Required: May require up to approximately 20% travel

Qualification Requirements:

Knowledge, Skills & Abilities
Strong understanding of global CGMP and how to apply in a phase appropriate manner during development.
Strong understanding of compliance requirements for the manufacture of API and sterile filled, finished drug product, sterile combination or device products including release of product from contract sites.
Strong technical understanding of sterile product manufacturing technology and associated principles such as sterilization, risk management, qualification/validation, contamination control.
Experience working with contract manufacturing and testing facilities.
Experience performing supplier audits (i.e., API starting materials, finished API, sterile-filled finished drug product, device components and finished device manufacture, and analytical testing laboratories)
Ability to read, develop, and understand procedures and other controlled documents.
Thorough knowledge and understanding of the current FDA regulations; including 21CFR Part 211; Good Manufacturing Practices (GMP), 21CFR Part 11, Electronic Records; Electronic Signatures; 21CFR Part 820, Quality System Regulation; 21CFR Part 4 for Combination Products; International Conference on Harmonization (ICH) guidelines; ISO 13485, Medical Devices Quality Management Systems.
Knowledge and recognition of other regional regulatory requirements including European, Japan and Asia.
Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.
Experience with online learning management systems for training (e.g. Compliance Wire) and electronic document and quality management systems (i.e. Veeva Quality Docs; eQMS).
Experience of hosting, managing and/or participating in GMP inspections by FDA and/or global regulatory authorities.

Education & Experience
B.A. or B.S. degree in a scientific field (e.g., chemistry, biology, or pharmacology), advanced degree in Chemistry preferred.
10+ years’ experience in a pharmaceutical or medical device environment with 5+ years working in a QA leadership role supporting API and/or drug product manufacturing across multi-disciplinary teams.
Experience of quality management systems for combination product development or manufacturing is highly desirable.
People and cross-functional project team management experience.

Training Requirements:
Training to pertinent quality-related procedures, documents, and methodologies, safety, GMP/GLP/GCP/ICH requirements, and auditing.