- Acts as Key Account Quality Manager for selected customers
- Leads & supports Audits & Regulatory Inspections at the Site
- Leads and directs staff in both QA and QC and ensures their development
- Develops compliance related manufacturing and process controls and improves quality systems
- Holds responsibility for Quality budget and driving Operational Excellence
- Member of the Site Leadership team
- BS degree in a Life Sciences, Engineering or Quality Management or related science discipline
- Highly experienced in GMP manufacturing and Quality Management of products regulated by FDA CBER or CDER or EMA
- Proven experience in senior leadership positions
- Must have prior aseptic processing experience
- Proven experience implementing CI initiatives to drive Quality programs and ensure maximum productivity. Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
- Past experience developing, implementing and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
- Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.
- Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza's long-term objectives.
- Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
- Represent the Lonza on quality and cGMP compliance issues that are specific to the site.
- Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested.
-
Quality Head, Cell
2 weeks ago
Lonza America, Inc. Portsmouth, United StatesThe Site Quality Head CGT will lead the Quality organization (QA & QC) and will assure the site remains under control with respect to GMP, collaborating with Operations to solve quality issues. Accomplishes corporate business objectives by developing Technology, Quality, Leadersh ...
-
Aircraft Mechanic I
2 weeks ago
V2X Norfolk, United StatesOverview · About Us · Working across the globe, V2X builds smart solutions designed to integrate physical and digital infrastructure from base to battlefield. We bring 120 years of successful mission support to improve security, streamline logistics, and enhance readiness. Aligne ...
-
Strategic Direct Solutions, LLC Virginia Beach, United StatesJob Description · Job DescriptionTelecom Installation Technicians - COEI - Primary & Secondary Power · Strategic Direct Solutions, LLC is looking for Telecommunications Technicians that specialize in Battery Plant Installation, with experience in Cell Sites, Central Offices or Ca ...
-
Medical Device Sales Rep
2 weeks ago
Salestars Virginia Beach, United StatesOur client is a growing privately held medical device company which is expanding nationally. They are seeking a proven outside B2B sales representative to sell a proprietary product into hospitals. Sales representatives should be driven, goal oriented and understand how to penetr ...
-
Supervisory Histopathology Technologist
4 days ago
Department of Veterans Affairs Hampton, United StatesSummary · This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of appoi ...
-
Toddler Leader/Assistant
2 weeks ago
First Discovery Academy Virginia Beach, United StatesJob Description · Job DescriptionSalary: $14.50-$16 DOE · Negative people, gossipers, and whiners need not apply. · If the following statements resonate with you, come see us immediately.... · 1. You MUST love to give hugs, wipe boogers, hold a crying toddler, get a dental ins ...
-
Executive Assistant
1 week ago
LifeNet Health Virginia Beach, United StatesEXECUTIVE ASSISTANT · Location: Virginia Beach, Virginia (on-site) · Department: Administration · Job Type: Full-Time · Shift: Monday - Friday, 8:15AM-5:00PM, Overtime as Needed · Clinical Classification: Non- Clinical · LifeNet Health is searching for talented individuals who wi ...
-
Head Night Custodian
1 day ago
Robbinsdale Area Schools New Hope, United StatesPosition Type:Maintenance/Custodial/Bus/Head night custodian · Date Posted:1/2/2024 · Location:Building to be determined · Closing Date:Open until filled · POSITION AVAILABLE · Head Night custodianMiddle School TBDMajor functions: Supervise building custodial staff, maintain ...
-
Regional Head, Real Estate Research
3 days ago
Green Street Newport Beach, United States: · **Responsibilities** · The Regional Head will be responsible for the following key job functions: · - Demonstrate a solid understanding of Green Street's views, research framework, methodologies and process · - Be able to place the assigned region and markets in the context o ...
-
Battle Management-Joint Fires Targeting SME
3 weeks ago
Federal Staffing Solutions Inc. Hampton, United StatesWe connect our employees with some of the best opportunities around. · Time and time again, our employees tell us that the most important thing we offer is respect. Federal Staffing Solutions puts people to work in all types of jobs. When you work with us, you build a relationshi ...
Quality Head, Cell - Portsmouth, United States - Lonza
Description
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
The Site Quality Head CGT will lead the Quality organization (QA & QC) and will assure the site remains under control with respect to GMP, collaborating with Operations to solve quality issues. Accomplishes corporate business objectives by developing site quality systems and enforcing Regulatory compliance. Responsible for providing the strategic leadership and management for the Site`s Quality organization. Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team. Ensures alignment with customer needs and linkage with the overall Quality and business strategies.
Key responsibilities:
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.