This incumbent will have overall responsibility for QA oversight to projects/programs requiring design control, technical and label review, and QA oversight of appropriate validation strategies for development and GMP processes that are in accordance with company policies, compliance with Novartis Quality Manual and per the guidelines and requirements of the Code of Federal regulations. In addition, provide key quality/compliance input to technical decisions involving process or analytic changes. This position will also serve on design and development project(s) as a QA technical resource and will interact with Process and Analytic Development Scientists to ensure that quality compliance requirements are understood while executing changes, investigations and product characterization. Consult with Technology Development group on scientific processes and process improvement, and new product development. This position will manage a team of Managers and Specialists who are responsible for creating and executing specific quality plans for design and development projects, guiding and influencing new product teams through design and into validation and verification, and interfacing to assure compliance and robust product vs. customer/product requirements. Additionally providing oversight of Validation for GMP manufacturing equipment, facilities, processes and methods.
o Change control review and approval associated with respect to Commercial Product or Design Control activities
- Define design document requirements for product, process and test methods in accordance with FDA QSR’s, ISO and specified Design Control Requirements.
- Provide QA representation for product development and design control teams.
- Provide QA review and approval of labeling printed materials, e.g., product inserts, user guides, training manuals, operating manuals, etc.
- Provide QA review and approval of all documentation related to product design and development and commercial launch.
- Apply risk management principles to assure fitness for use.
- Implement design control policies and procedures for a program or project.
- Provide guidance for external developers and assist in hazard/risk analyses.
- Interact with regulatory and partner auditors / inspectors as needed.
- Provide Quality and scientific expertise on Development Project teams
- Provide technical analysis and assessment of complex process or product investigations
- Quality oversight and approval of appropriate validation master plans, strategies and risk assessments
- Lead team and provide strategic guidance on validation deviation investigations or product investigations.
- Set strategy on validation of manufacturing processes and standards related to associated validations.
- Develop, maintain and implement appropriate Validation programs for the Quality group
- Provide Quality and scientific technical expertise on Development Project teams
- Provide scientific review of quality programs which provide the basis for sound business and technical decisions.
- Provide oversight on technical protocols and quality reports generated to support development activities and Regulatory submissions.
- Ensure Quality Compliance is upheld through Development activities.
- Determine and/or recommend direction taken in technical product or manufacturing issues.
- Leads process improvements projects.
- Exercises independent judgment in quality assurance related activities.
- Coach and provide guidance and ongoing developing to staff
- Additional duties may include:
o Revise/initiate Standard Operating Procedures as requested. Minimum requirements Ideal Background:
- B.S. or M.S. in Chemistry, Biochemistry or related discipline. Ph.D. preferred.
- 15+ years of experience with a B.S., min of 12 years of experience with M.S. or 10+ years of experience with a Ph.D., in development of chemically or biologically manufactured products under cGMP.
- Knowledge of cGMP and Diagnostic regulations.
- Work in a cGMP and ISO regulated environment as well as within the scope of Novartis V&D internal policies and directives.
- Minimum of 8+ years of process validation experience in Quality environment
- Experience or technical familiarity with analytical methods such as: chromatography, SDS-PAGE, Lowry Protein, ELISA, Western Blot and microbial testing.
- Familiarity in characterizing chemical or protein products using standard analytical techniques for biological products such as: Amino Acid Analysis, n-terminal sequencing, or IR spectroscopy.
- Familiarity with fermentation processes that use E. coli, yeast or mammalian cells to make recombinant proteins.
- Familiarity with protein purification using chromatography, ultrafiltration and centrifugation.
- Experience in process transfer from development to production.
- Experience in methods transfer from development to QC.
- Experience in validating analytical methods for licensed products.
- Experience in selecting, qualifying and managing outsourced production processes.
- Must have working knowledge of FDA/ ICH guidelines, applicable regulations and standards routinely used in the industry, validation principles.
- Experience working on process improvements.
- Must have strong written, verbal and presentation skills as well as a strong sense of customer service and professionalism.
- Good knowledge of project management and work well in team environment.
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...