Senior Manager Quality Control Support Job at Amgen (Holly Springs)

Senior Manager, Quality Control Raw Materials

The QC Manager, Raw Materials will be responsible for developing, leading, and m...

Location

United States , Durham

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's or advanced degree in biology, biochemistry or closely related scientific discipline
At least 7-10 years of CGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required
Expert knowledge of pharmaceutical/biotech Raw Materials testing is required
At least 3 years of management experience is required
Basic knowledge of qualifications and validations
current industry practices
and strong experience with guidance interpretation and application
Knowledge of cGMPs, ICH, USP, FDA requirements is required, including equipment and method validation/verification
Experience with risk assessment tools is desired
Excellent critical thinking and technical writing skills

Job Responsibility

Build and manage the raw materials QC program at the Beam Therapeutics Manufacturing facility
Develop and maintain all documentation with regards to testing requirements and strategies, including material specifications
Serve as a SME for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices
Manage contract laboratories as needed
Own and author risk assessments for raw material programs
Support supplier change notifications and material enrollment
Identify need for development of new assays with compendial and GxP requirements
Accountable for managing the raw materials testing program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents
Evaluate QC systems and recommend and/or implement system improvements
Author technical protocols and reports for Raw Materials testing qualification, validation, or verification

Fulltime

New

Manager Quality Control (Micro and Sample Management)

Manager Quality Control (Micro and Sample Management) at Amgen Singapore Manufac...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality or Operations related experience
OR Bachelor's degree and 4 years of Quality or Operations related experience
OR Diploma and 8 years of directly related experience
Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
Ability to lead diverse teams
Good communication skills (technical writing and verbal communication/presentation)
Ability to work in cross-functional and multisite teams

Job Responsibility

Lead and supervise QC Microbiology Shift teams
Maintain the weekly lab schedule and prioritize daily work tasks
Provide Quality oversight to ensure processes follow cGMP
Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP
Perform review, approval and tracking of cGMP processes, procedures, documents and records including nonconformance records and CAPAs
Oversee day to day activities in microbiology (routine environmental & utilities monitoring
raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID
media, reagent and culture qualification such as growth promotion
etc.)
Oversee sample management and stability (sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.)

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Quality Manager

Are you an experienced Quality professional looking to join a company with a fan...

Location

United Kingdom , Swindon

Salary:

65000.00 - 75000.00 GBP / Year

Kenton Black

Expiration Date

Until further notice

Requirements

Educated to degree level or equivalent in a relevant subject matter
Experienced in Quality Assurance and Quality Control (QA/QC)
Knowledge of EDMS systems
Comprehensive understanding of document control processes including ISO 19650
Good communication and presentation skills
Lead Auditor/Assessor ISO 9001 qualification
Knowledge of ISO 9001 with an understanding of the requirements of ISO 140001 and ISO 45001

Job Responsibility

Providing quality and systems related support to regional projects, before, during and after construction
Supporting with training, technical knowledge and lessons learnt sharing with regional teams & other peers
Reviewing Root Causes to identify where improvements to the Management System can be made to prevent recurrence
Providing quality and systems related support to regional projects, before, during and after Construction
Offering guidance and support to regional teams in the correct use of core tools and systems
Presenting monthly reporting for Regional Directors and summary reports for the Board

What we offer

Plus car and package
accommodation and travel package

Fulltime

Data Quality Senior Manager - Vice President

The Data Quality Senior Manager is responsible for leading a team of Data Qualit...

Location

Philippines , City of Taguig, Metro Manila

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

6-10 years relevant experience with defining and implementing Data Quality programs. 3+ years managerial/supervisory experience in Banking or Finance industry preferred
Communicates effectively, develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences
able to drive consensus, and influence relationships at all levels
Collaborates effectively by building partnerships and working well with others to meet shared objectives
Ability to work under pressure, facilitate discussions
Strong negotiation, influencing and stakeholder management skills across a variety of stakeholders at different levels
Bachelor's/University degree, Master's degree preferred

Job Responsibility

Lead a team of Data Quality Analysts to ensure high-quality data across multiple business areas or functions
Oversees management of people, budget and planning, to include duties such as performance evaluation, compensation, hiring, disciplinary action and terminations
Defines strategies to drive Data Quality measurement, produce Data Quality dashboards and reports, and implement Data Quality strategies to effectively govern data and improve Data Quality
Lead data improvement initiatives, processes, and creation of tools in line with requirements
Develops standards, procedures and guidelines for businesses and functions to better address Data Quality Management socialization and validation of these standards, procedures and guidelines
Integrate subject matter expertise to guide the relationships with Data stakeholders with documentation of Data Quality standards, procedures and requirements in line with Cit’s guidelines and Operating Model
Influences decisions through advice, guidance and/or facilitating services to others in area of specialization
Report Data Quality issues through Citi’s corresponding Data/Issue management process
Contributes to the development of new techniques and processes for the assigned business or area
Oversee activities that support data quality resolution, and to optimize metrics reporting process

Fulltime

Senior Control Manager (CTO Infrastructure – Enablement Lead)

Your career opportunity: The GCIO Chief Control Office (CCO) team plays an impor...

Location

Poland

Salary:

21141.00 - 31708.00 PLN / Month

HSBC

Expiration Date

July 01, 2026

Requirements

At least 5 years of hands-on experience within IT infrastructure and technology control capabilities either directly or as a 1/2/3LOD control management function
Previous experience leading teams required with remote team leadership experience preferred
At least 5 years of hands-on experience and subject matter expertise in management of operational risk, non-financial risk and/or technology & cyber risk
Experience across Data, IT, Risk Management, and / or Audit roles requiring management of diverse risk types is desirable
Previous experience of identifying, defining and solving problems that have impact on your work or the wider business
Financial Services or other highly regulated industry experience/exposure is preferred
Strong communication skills to influence and challenge stakeholders
Experience dealing with regulatory bodies engagement
Active industry recognized certificates will be an asset, e.g. CISA, CISSP, CRISC, CCSP etc.

Job Responsibility

Partner with the GCIO CCO function to oversee the risk and control portfolio related to the services CCO CTO provides to the Group
Lead a specialist control team within the GCIO Chief Control Office (GCIO CCO) Function that directly supports the Technology Infrastructure area of the Chief Technology Office within HSBC, who own the design of controls for the Bank: Configuration Baselines, Evergreening/Obsolescence, IT Asset Management, Capacity Management, IT service Acceptance, and manage infrastructure compliance with a wider set of controls such as Third Party and various Cyber requirements
Act as trusted advisor for senior management by partnering to manage their operational risk i.e., risk assessments, control environment, issues management, audits
Promote accountable risk and control decision-making based on quality data and analysis, actively challenging poor, inefficient or excessive controls, related tasks and behaviours
Provide specialist risk and control knowledge and insights, leading efforts to continuously improve the control environment and monitoring of risk, including behaviours
Advise and designing process and controls in a commercially viable, practical and effective manner
Identify trends to anticipate future developments in the risk and control environment
Influence and shape the development and implementation of future-fit risk management and regulatory frameworks
Provide Senior Management with updates on any relevant changes to policy or projects related to operational risk that have an impact on their area of responsibility

What we offer

Additional bonuses for recognition awards
Multisport card
Private medical care
Life insurance
One-time reimbursement of home office set-up (up to 800 PLN)
Cafeteria platform
Employee assistance program
Additional contributions to PPK scheme
Corporate parties & events
CSR initiatives

Fulltime

!

Senior Manager - Quality Services

We are launching people to the Moon and Mars. If you want to be part of this ama...

Location

United States , Kennedy Space Center

Salary:

Not provided

Amentum

Expiration Date

Until further notice

Requirements

Bachelor’s degree from accredited college or university field plus ten (10) years of progressive and relevant experience
Additional relevant education may be substituted for progressive experience
Excellent communication, presentation and customer interface skills required
Ability to manage and prioritize multiple projects
Computer experience with Microsoft Office products, Internet browsers, and Outlook
Excellent Excel skills to manipulate and analyze data to generate reports in a variety of formats
Must have the ability to obtain and maintain a security clearance, if necessary

Job Responsibility

Provides overall management and implementation of ground systems capabilities, flight hardware processing and launch operations at NASA's Kennedy Space Center in Florida
Provides leadership to the Quality Team supporting NASA's Space Launch System, International Space Station, Launch Service Provider
Internal Audit maintains compliance with AS9100D
Quality Engineering develops and executes processes that maintain and monitor the use of calibration equipment, enable quality planning for work execution, monitor non-conformances, establish corrective and preventive action, review acceptance data packages, support still imagery, and monitor foreign object debris prevention
Software Assurance develops and executes processes detailing safety software assessments of critical systems, monitor verification and validation of the Launch Control System and ensuring compliance with a CMMI ML3 software development process
Supplier Quality develops and executes processes to flow down supplier requirements, perform supplier quality audits and carry out supplier source inspections
Inspection performing receiving, flight hardware manufacturing, and work execution acceptance on flight hardware and ground support equipment
Develops and implements Quality goals, policies, priorities, and procedures
Ensures adherence to master plans and schedules develops solutions to program problems and directs work of incumbents assigned to program from various departments
Ensure projects are completed on time and within budget

What we offer

Health, dental, and vision insurance
Paid time off and holidays
Retirement benefits (including 401(k) matching)
Educational reimbursement
Parental leave
Employee stock purchase plan
Tax-saving options
Disability and life insurance
Pet insurance

Fulltime

Sr. Manager Quality Control - Chemistry

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Holly Springs

Salary:

142103.85 - 192258.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Aseptic Manufacturing experience OR Associate’s degree and 10 years of Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Aseptic Manufacturing experience OR Master’s degree and 6 years of Aseptic Manufacturing experience OR Doctorate degree and 2 years of Aseptic Manufacturing experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations
Include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina
Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations
Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing
Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing
Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements
Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations
Implement effective digital tools for leading the organization
Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations
Participate in regulatory agency inspections and support site licensure and inspection readiness activities

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior Manager, Quality - Microbiology

At Baxter Healthcare Corporation, we are deeply committed to improving patient o...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework. A graduate degree in Microbiology or related field is desirable
A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience
In-depth knowledge of pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards
Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions
The ability to manage and supervise a team of employees
Proven leadership skills with the ability to effectively manage, engage and develop teams
Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas
Strong change leadership capabilities and experience supporting enterprise-level initiatives

Job Responsibility

Provide overall direction and leadership for microbiology laboratory operations to ensure results consistently meet product quality, safety, and performance standards
Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements
Ensure full compliance with applicable regulations in the including FDA, USP and cGMP requirements within the microbiology laboratory
Serve as a primary quality microbiology liaison during regulatory inspections
lead preparation activities and develop effective, timely responses to regulatory observations
Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans
Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability, efficiency and cost effectiveness
Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards
Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements
promote a strong safety culture

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

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Senior Manager Quality Control Support

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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