The Quality Assurance Manager of Combination Products will be responsible for providing quality oversight of Novartis suppliers and support for Novartis combination product development efforts throughout clinical development, product registration, commercialization, and lifecycle management.
The Manager is responsible for supporting the start-up and routine manufacture of a new sterile injectable generic product. Responsibility will include key roles in the end to end quality management for a new generic product manufactured at multiple contract manufacturing organizations. Quality management will include drug substance manufacturing, drug product manufacturing, analytical testing, components, and raw materials.
Reviews and approves requirement documents, specifications, verification and validation plans and protocols, reports and other related design control elements.
Drives the creation of an appropriate Risk Management Plan at the start of a project and maintains the plan through all phases of development; supports risk assessment activities through UFMEA, DFMEA, PFMEA and other QA risk analysis techniques in order to manage potential risk during development and commercialization.
Participates in design review meetings and provides technical quality input.
Reviews vendor change notices and change control documentation to ensure a thorough review of quality documents submitted for product design changes or manufacturing changes conform to the Design Control requirements.
Identifies deliverables and establishes documentation required for project support in accordance with applicable SOP s.
Represents the company as the combination product QA expert during regulatory inspections and internal audits.
Assists in the troubleshooting and directs the resolution of complex quality issues during design and development and during design transfer.
Works with the global team to develop and implement quality systems SOPs for medical devices and combination products.
Provides support for all compliance activities such as Management Reviews, industry standards assessment, training, deviation and CAPA management, and change control.
Leads design control gap assessments and remediation as required.
Provides combination product and medical device training to internal groups.
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual and is conducted according to the relevant SOPs.
Leads the External Suppliers Qualification process.
Acts as the Single Point of Contact / SPOC for all quality related activities at the External Supplier.
Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement, that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed.
Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements.
Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed.
Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Support / participate in Novartis Emergency Management cases as required
The number and severity of cGMP issues identified during internal Global Quality Organization and Health Authority audits of External Supply QA and the External Supplier Compliance of products according to agreed specifications
No out of stock incidents related to QA activities
Training plans in place with training conducted, assessed and documented
execution of responsibilities in a timely and efficient manner
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
B.S. Degree in Science or Engineering with a minimum of 8 years of pharmaceutical industry experience. (Experience can include manufacturing, technical operations, validation, or quality).
Written and oral English
Experience working on cross-functional teams.
Experience leading and implementing projects. Preferred but not required:
Experience with sterile operations including deviations, batch records, validation, equipment sterilization, environmental monitoring, aseptic manufacturing, analytical release testing.
Six Sigma Green Belt or Black Belt certification.
American Society for Quality CQM/CQE/CQA or similar certification. Skills & Competencies:
Knowledge of quality systems, code of federal regulations, and industry guidance for sterile and non-sterile pharmaceutical manufacturing.
Excellent verbal/written communication and decision making skills.
Strong project management skills.
Knowledge of quality by design principles and how to define critical process parameters.
Strong understanding of regulatory requirements for commercial products
Proven track record with FDA, EMEA and other Health Authorities.
Strong understanding of risk assessment and risk management fundamentals/tools
Strong Technical understanding of pharmaceutical processes
Team and consensus builder, with definitive and authoritative decision making abilities
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