Senior Manager QA Site Compliance

1 week ago

Holly Springs, United States CSL Seqirus Full time

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.As the Senior Manager QA Site Compliance you will be reporting to the Sr. Director, Quality Assurance & Quality Site Head. You will be you will work onsite at our CSL Seqirus in Holly Springs, NC location Monday-Friday during primary business hours. Benefits Include flexible hours M-F, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.Responsibilities:Build and manage a collaborative, high performing team of quality assurance professionals by clearly defining expectations, holding individuals accountable, managing prioritization/workload allocation, recognizing accomplishments, managing performance, and ensuring professional development.Manage the internal self-inspection program in accordance with global procedures to ensure compliance with local and global GMP expectations, regulations and requirements.Manage external domestic and international Regulatory Inspections including audit readiness activities, inspection preparation and logistics, communications, and post inspection deliverables.Manage and coordinate assigned deliverables for Local and Global Quality Management Reviews and site compliance including but not limited to the Site Quality Plan, key performance indicators, regulatory intelligence and gap assessments, and other compliance responsibilities.Acquires and maintains knowledge of local and international regulatory and legislative requirements for pharmaceutical current good manufacturing practices and trends, for all markets to which the site distributes product and utilize this knowledge to implement continuous improvement at the site.Qualifications/Position Requirements:Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry, Engineering); advanced degree preferred7+ years' experience in GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experienceMust have GMP and risk management knowledge and experience, prior experience in Quality preferredDemonstrated organizational skills, and experience with regulatory inspections.Experience operating within a global matrix organization and demonstrated ability to influence key stakeholdersStrong project management skills with proficiency in Quality Management SystemsKnowledge of appropriate regulatory requirements including GMP/GQP/GDP, etc.Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.#LI-OnsiteOur BenefitsCSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.We want CSL Seqirus to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.Do work that matters at CSL SeqirusWatch our ‘On the Front Line’ video to learn more about CSL Seqirus

  • Senior Manager QA Site Compliance

    2 days ago

    Holly Springs, United States CSL Plasma Full time

    Senior Manager QA Site Compliance page is loaded Senior Manager QA Site Compliance Apply locations Seqirus USA - NC - Holly Springs time type Full time posted on Posted 2 Days Ago job requisition id R-235146 Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to...

  • Senior Manager QA Site Compliance

    6 days ago

    Holly Springs, United States CSL Full time

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as...

  • Senior Manager QA Site Compliance

    1 week ago

    Holly Springs, United States CSL Seqirus Full time

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as...

  • QA Specialist

    4 weeks ago

    Holly Springs, United States PharmEng Technology Americas Full time

    Job DescriptionJob DescriptionQA Specialist PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on...

  • QA Engineer

    2 weeks ago

    Holly Springs, United States FUJIFILM Corporation Full time

    OverviewJoin usWe are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North...

  • QA Engineer

    2 weeks ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Overview Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in...

  • QA Engineer

    7 days ago

    Holly Springs, United States Fujifilm Corporation Full time

    Overview Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO...

  • Senior Manager Supply Chain

    2 weeks ago

    Holly Springs, United States Amgen SA Full time

    HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...

  • Senior Manager Supply Chain

    3 weeks ago

    Holly Springs, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Manager Supply Chain

    2 weeks ago

    Holly Springs, United States Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...

  • Compliance/qa/admin

    3 weeks ago

    Palm Springs, United States Haven Health Management Full time

    Compliance/QA/Admin position needed. **RESPONSIBILITIES**: - Must have experience with Joint Commission, State Compliance and Facility Regulations. - Experience with Facility Inspection, Environment of Care, Clinical Records Requirements, Medical Standards and requirements. - Proficient in Excel and data collection. - Working knowledge of levels of care,...

  • Senior Manager Supply Chain

    4 weeks ago

    Holly Springs, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • QA/qc Manager

    3 weeks ago

    Santa Fe Springs, United States CSI Electrical Contractors Full time

    About the Role: To ensure all work being performed on renewable energy projects adhere to contractual, technical, installation requirements, and industry standards. Lead the efforts to develop, implement, maintain, and continually improve a comprehensive quality control/quality assurance program according to CSI Quality Management System (QMS) **Company...

  • Manager Compliance

    4 weeks ago

    Holly Springs, United States First Citizens Bank Full time

    Overview: This position manages compliance associates, initiatives, and activities that reduce risk and ensure regulatory compliance for the Bank. Oversees enterprise-wide initiatives with significant impact on daily processes. Leads the analysis and communication of new or changing regulations. Represents compliance efforts on business projects and...

  • Site Manager

    1 month ago

    Holly Springs, United States RoviSys Full time

    Overview: Site Managers are responsible for overseeing field operations associated with building automation projects. During the construction phase of a project, the Site Manager is an RBT representative to the general contractor as well as other trades. In between project deployments, the Site Manager will assist with new project estimating and systems...

  • Site Manager

    2 months ago

    Holly Springs, United States RoviSys Full time

    Overview: Site Managers are responsible for overseeing field operations associated with building automation projects. During the construction phase of a project, the Site Manager is an RBT representative to the general contractor as well as other trades. In between project deployments, the Site Manager will assist with new project estimating and systems...

  • EHSS, Senior Manager

    4 weeks ago

    Holly Springs, Georgia, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • EHSS, Senior Manager

    1 month ago

    Holly Springs, Georgia, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Senior Automation Engineer

    2 months ago

    Holly Springs, United States Piper Companies Full time

    Piper Companies is searching for a Senior Automation Engineer to join a company focused on delivering affordable and innovative drugs to patients worldwide in the Raleigh-Durham, NC area. The Senior Automation Engineer will join a brand new pharmaceutical manufacturing facility and will be the subject matter expert for the design and implementation of...

  • Senior Automation Engineer

    4 weeks ago

    Holly Springs, United States Piper Companies Full time

    Piper Companies is searching for a Senior Automation Engineer to join a company focused on delivering affordable and innovative drugs to patients worldwide in the Raleigh-Durham, NC area. The Senior Automation Engineer will join a brand new pharmaceutical manufacturing facility and will be the subject matter expert for the design and implementation of...