Senior Manager, Quality Assurance QMS and Disposition
Place in the Organization
The Quality Assurance QMS and Disposition Sr. Manager is responsible for the disposition of raw material, drug substance and drug product. The candidate is also responsible for leading the organization to establish and implement a robust internal QMS system. The candidate will ensure the current quality practices and standards at internal sites are compliant with regulatory requirements and internal standards. This role requires strong cross functional collaboration.
Key result areas (major duties, accountabilities, and responsibilities)
- Effectively manages relationship with internal stakeholders to ensure operational and quality alignment on time in order to meet timelines.
- Lead and/or support continuous improvement initiatives related to QMS.
- Manages the final review of External Quality documentation and ensures timely and accurate internal alignment for proper completion.
- Collaborate with other Quality leaders to ensure compliance with all relevant Quality Management Systems and processes are maintained and in line with global regulations and in alignment with the company's strategy.
- Develop SOPs, guidelines, training material and video tutorials to drive continuous improvement efforts.
- Conduct ongoing and comprehensive documentation and training needs assessment ensuring global process improvement.
- Manages the final review of disposition Package received by CMOs and ensures timely and accurate alignment with External Quality for meeting compliance and timelines.
- Review and approve Change Controls and Change Notifications ensuring quality impact, validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
- Review and approve internal/ external deviations and CAPAs, including performing Failure Mode Effect Analyses (risk assessments) where applicable, participating in root cause analysis investigations and evaluating CAPA effectiveness.
- Review and approve Out of Specifications, Environmental Monitoring Excursions and other Laboratory investigations including subsequent deviations and CAPAs.
- Provide inspection readiness support for third-party audits and regulatory inspections.
- Responsible for assessing the impact of any new or updated regulations on the disposition process.
- Compile metrics related to Document Control, Training, and QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls and OOS for Quality operations reports
- Represent Quality Assurance on project teams and in meetings.
#LI-EB1
- A minimum of a bachelor’s degree in Life Sciences/Chemistry/ Pharmacology/ Biotechnology/ Biology
- Post graduate studies in Pharmaceutical Business and/ or Technology
- 10+ years of relevant GMP experience in pharma/biotech company in Operation and Quality roles, working within a quality system and regulated GMP environment
- Experience working in a GMP manufacturing environment
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
- Experience using Risk Management Tools such as FMEA, 5Ms, 5 Whys, etc.
- Internal and/or External audit experience is required
- Advanced knowledge of global, especially US and EU, GMP guidelines
- Experience in regulatory inspections and interactions, especially FDA and EMA
- Ability to collaborate and influence to effect change both within and outside the organization
- Confident, independent, self-starter, proactive, and results-orientated with high performance standards
- Strong communication skills
- Strong organizational skills
- Decision making and problem-solving skills
- Attention to detail
- Capable of working with minimal supervision
- Ability to work well with diverse groups
- Ability to multi-task in a fast-paced environment with changing priorities
#LI-EB1