Sr. Manager, Quality Control (Immunology)
The Senior Manager provides oversight of two independent laboratories which are responsible for strategic and technical expertise for the US FCC HS facility as well as delegation of authority for the Director of QC. This individual is the Immunology subject matter expert for global supply of vaccines in collaboration with the Technical Development group. The Senior Manager of Immunology is responsible to define and implement the strategy to utilize a lean organization which can successfully release high volumes of samples generated in the development organization or commercial organization over very condensed periods of time throughout the entire manufacturing process. The role represents the QC department on the site Biosafety committee. This individual is accountable for managing communication with both internal and external regulatory collaborating centers.Major Accountabilities:
- Serves as the QC Immunology single point of contact for Holly Springs, supporting global product testing, validation/qualification activities; assay development/improvement activities, technical transfers and routine testing
- Leads with a strong safety mindset that ensures the highest level of safety is adhered to and a speak up for safety culture is endorsed
- Drives a strong team performance & accountability that aligns with our core values & behaviors as well as the company leadership capabilities
- Ensures test methods, qualification, validation, and technical protocols, GLIMs builds and reports comply with site SOPs.
- Provides QC oversight to equipment qualification and validation in areas owned by Senior manager
- Primary QC reviewer for regulatory filings for area
- Collaborates with AS&T for assays under development to ensure staffing and support are adequate for execution of studies
- Collaborates with MS&T to complete performance monitoring/new strain verification studies
- Collaborates with Manufacturing, Batch Disposition and Regulatory to ensure timely completion of Annual Strain Update and batch release activities for all Influenza products
- Serves as Accountable person for two laboratories, Biochemistry and Virology in Holly Springs.
- Biochemistry: responsible for Drug Product and Raw material release testing
- Virology: responsible for Virus seed testing, working cell banks, drug substance and drug product testing.
- Accountable to ensure development of all levels of organization, as well as overseeing the strategy of the organization in alignment with Seqirus’ 2030 strategy & beyond
- Ensures teams operate to budget and efficiently sustains testing capacity to meet site production plan while maintaining the highest degree of compliance
- Builds, manages and develops high performing cross-functional teams by clearly defining expectations, holding individuals accountable, recognizing accomplishments & rewards as appropriate
- Ensures effective professional development of direct reports, through combination of coaching, mentoring and effective development planning
- Complies with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and environment, health and safety (EHS) policies.
- Ensures collaboration of own department with other functions and departments to achieve business and site objectives
- Maintains in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to cGMP Quality Assurance activities.
- Bachelor’s degree in Science / Engineering or other discipline required.
- 7+ years industry experience with knowledge of Biochemistry / Cellular Virology preferred
- 5+ years experience independently leading a team. Manager role preferred
- Ability to deliver and drive results in a fast-paced environment
- Demonstrated experience and good working knowledge of method development, method validation, troubleshooting and analytical method transfer.
- Demonstrated leadership experience in Quality Control and/or in a GMP regulated environment within the pharmaceutical industry
- Sterile product manufacturing knowledge and/or Biopharmaceutical experience required.
- Strong leadership and communication skills with special emphasis on collaboration skills and experience within matrix / multi-disciplined team environment preferred
- Very good prioritization, organizational, communication, and negotiating skills
- Ability to motivate, develop, and inspire team members and direct reports.
- Demonstrated knowledge of global regulatory frame-works.
- Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally.
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Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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