Director, Global Supplier and External Manufacturing Quality Job at Alfasigma

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Sr. Director, QC Analytical Methods

The Sr. Director, Quality Control, Analytical Methods will provide strategic lea...

Location

United States , Durham

Salary:

250000.00 - 310000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s or advanced degree in scientific discipline
Minimum of 18 years’ experience in the pharmaceutical/biotech industry, encompassing drug substance/drug product manufacturing, development, and/or quality
Direct experience with cell and/or gene therapy programs is strongly preferred
Experience with implementing, validating, and overseeing execution of automated test methods
Proven experience leading teams in Quality and Quality Control functions
Demonstrated support for all phases of a program’s lifecycle (pre-IND through commercial lifecycle management)
At least 10 years of Quality management experience
Exceptional verbal and written communication skills, with a detail-oriented approach and the ability to drive change across functions
Experience engaging with regulatory health authorities during pre- and post-approval inspections
In-depth knowledge of global regulations and standards

Job Responsibility

Deliver comprehensive Quality Control leadership across multiple programs and cross-functional forums
Develop and implement robust QC strategies for method qualification, transfer, and validation in collaboration with Analytical Development and other key stakeholders
Provide strategic direction to Quality Control teams in North Carolina and Massachusetts, ensuring excellence in method lifecycle management and product quality testing and stability
Serve as a QC leader in interactions with Beam’s suppliers and the internal manufacturing site in Durham, North Carolina
Establish and monitor metrics for all testing aspects, including in-process, release, stability testing, and OOT/OOS results
Partner with Quality Assurance to ensure contract laboratory service providers are appropriately qualified and that Quality Agreements are comprehensive, approved, and regularly updated
Ensure strict adherence to GMP principles within internal and external laboratories
Maintain compliance of quality control systems and equipment with all applicable regulatory guidelines, upholding data integrity to ensure confidence in generated data
Track and analyze GMP data, including the evaluation and approval of data from external contract laboratories
Compile and present data with insightful interpretations for management reviews, Annual Product Reviews, and other required assessments

Fulltime

Senior Director of Quality

HPE is seeking a strategic, customer-focused Senior Director of Quality to lead ...

Location

United States

Salary:

161000.00 - 389500.00 USD / Year

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, quality assurance/quality management, or a related field. Master’s degree preferred
10+ years of progressive quality leadership experience, including 5+ years in a senior leadership role managing global teams across hardware, software, and services
Proven experience within complex products and complex supply chains
prior experience in HPC, AI, networking, storage, or comparable high-tech industries encompassing one or more quality management domains is preferred
Proven ability to build and scale QMS and quality programs within complex organizations
Deep knowledge of quality systems, methodologies and tools (Six Sigma, Lean, APQP, FMEA, risk management, root cause analysis). Strong problem-solving and data-driven decision-making skills
Experience with regulatory standards and certification processes (ISO, industry specific)
Experience with supplier quality management, including supplier qualification, audits, and remediation
Proficiency in quality management software and enterprise systems
Strong leadership and people management abilities

Job Responsibility

Define and drive the business unit’s quality strategy, standards, and metrics to ensure product quality, regulatory compliance, and customer excellence
Lead and advance the Quality Management System (QMS), including document control, change control, CAPA, nonconformances, deviation handling, and supplier quality management
Lead, mentor, and develop a high-performing, cross-functional Quality organization by setting clear objectives, tracking performance, developing talent, and fostering a quality-first culture
Collaborate with Product & Engineering leadership to influence design for reliability, testability, manufacturability, and serviceability. Ensure design quality, implement design controls, conduct DFM/DFMEA, participate in design reviews, and develop verification and validation strategies
Ensure compliance with applicable regulations and standards such as FDA, EMA, ISO 9001, ISO 13485, GMP, and GMP-like requirements. Coordinate internal and external audits, inspections, regulatory submissions, and remediation activities
Partner with Supply Chain and Procurement to manage supplier quality, including qualification, performance management, corrective actions, and continuous improvement
Own root cause investigations for systemic quality issues, lead cross-functional corrective actions and verification of effectiveness
Lead risk management activities including FMEA and risk assessments, conduct product safety evaluations, and oversee post-market surveillance to proactively manage risk
Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance quality, yield, throughput, and customer satisfaction. Manage quality-focused kaizen events and project portfolios
Prepare and present quality metrics and reports to senior leadership, translating data into actionable insights and strategic recommendations

What we offer

Health & Wellbeing
Personal & Professional Development
Unconditional Inclusion

Fulltime

Director of Quality and Regulatory Affairs

The Director of Quality and Regulatory Affairs leads the global QA/RA function a...

Location

United States , Burlington

Salary:

170000.00 - 180000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, technical, or related discipline
advanced degree preferred
8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience
5+ years of experience with Class I and/or Class II medical devices
Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions
Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls
Experience managing Quality Management Systems (QMS) for medical devices
Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred)
Demonstrated experience leading QA/RA teams, including talent development and performance management
RAC certification or equivalent is preferred

Job Responsibility

Lead the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy
Ensure compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle
Partner cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes
Contribute to the development and lead execution of the Quality strategy
Lead departmental planning and budgeting, optimizing resources and operational efficiency
Direct QA/RA staff, including organizational design, talent development and performance management
Develop and continuously improve quality programs, policies, and processes
Ensure Quality Management System (QMS) processes are established, implemented, and maintained
Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities
Oversee development and execution of global regulatory strategies for product submissions and lifecycle management

Fulltime

Global R&D Director Metal Design Innovation

Ardagh Metal Packaging (AMP) is shaping a sustainable and responsible future by ...

Location

Salary:

Not provided

Ardagh Group

Expiration Date

Until further notice

Requirements

Advanced degree (Master’s / PhD preferred) in Mechanical or Metallurgical Engineering
10+ years of experience in metal design & innovation
Proven leadership in global or multi-regional R&D environments
Strong expertise in FEA (Abaqus), CAD and advanced simulation
Experience with business case development, ROI and project financial impact
Familiarity with IP / patenting and comparative design reviews
Fluent English and willingness to travel internationally

Job Responsibility

Lead global metal design innovation by guiding regional R&D Directors and cross-functional teams, integrating advanced simulation, FEA and AI-driven optimization into can and end design
Translate customer and market needs into scalable design solutions, developing robust business cases that ensure regulatory compliance while delivering cost, efficiency and performance benefits in close collaboration with Manufacturing, Engineering and Suppliers
Own and drive a global portfolio of complex R&D projects, managing all stage-gates from concept through industrialization, plant rollout and commercialization, ensuring delivery on time and within budget
Build and lead specialized expert teams, defining resource needs, capabilities and capital investment plans aligned with AMP’s global innovation and lightweighting roadmap
Establish technical governance and methodologies for quality support, qualifications, testing and analytical services, enabling regions to effectively resolve quality and productivity challenges
Lead cross-regional and cross-functional innovation programs in partnership with key suppliers, technology partners and universities to accelerate next-generation can and end technologies
Develop and maintain strategic supplier relationships across metal design, DWI technologies and process innovation, acting as a key technical interface with internal and external stakeholders
Support global and regional marketing initiatives by enabling the development of new materials, designs and products that meet customer requirements and drive top-line growth
Define global quality standards and operational guidelines for new designs, lightweighting and downgauging technologies, ensuring consistency, safety and scalability across regions
Engage globally through regular international travel, including quarterly leadership meetings in North America, Germany and Brazil, and visits to manufacturing facilities worldwide to stay closely connected to regional complexities and opportunities

What we offer

To be a part of exciting and growing business
Global scope, real ownership and decision-making authority

Global R&D Director Metal Design Innovation

Ardagh Metal Packaging (AMP) is shaping a sustainable and responsible future by ...

Location

Multiple Countries , Chicago; La Ciotat; Radomsko; São Paulo; Chester; Bonn; Oss; Valdemorillo

Salary:

Not provided

Ardagh Group

Expiration Date

Until further notice

Requirements

Advanced degree (Master’s / PhD preferred) in Mechanical or Metallurgical Engineering
10+ years of experience in metal design & innovation
Proven leadership in global or multi-regional R&D environments
Strong expertise in FEA (Abaqus), CAD and advanced simulation
Experience with business case development, ROI and project financial impact
Familiarity with IP / patenting and comparative design reviews
Fluent English and willingness to travel internationally

Job Responsibility

Lead global metal design innovation by guiding regional R&D Directors and cross-functional teams, integrating advanced simulation, FEA and AI-driven optimization into can and end design
Translate customer and market needs into scalable design solutions, developing robust business cases that ensure regulatory compliance while delivering cost, efficiency and performance benefits in close collaboration with Manufacturing, Engineering and Suppliers
Own and drive a global portfolio of complex R&D projects, managing all stage-gates from concept through industrialization, plant rollout and commercialization, ensuring delivery on time and within budget
Build and lead specialized expert teams, defining resource needs, capabilities and capital investment plans aligned with AMP’s global innovation and lightweighting roadmap
Establish technical governance and methodologies for quality support, qualifications, testing and analytical services, enabling regions to effectively resolve quality and productivity challenges
Lead cross-regional and cross-functional innovation programs in partnership with key suppliers, technology partners and universities to accelerate next-generation can and end technologies
Develop and maintain strategic supplier relationships across metal design, DWI technologies and process innovation, acting as a key technical interface with internal and external stakeholders
Support global and regional marketing initiatives by enabling the development of new materials, designs and products that meet customer requirements and drive top-line growth
Define global quality standards and operational guidelines for new designs, lightweighting and downgauging technologies, ensuring consistency, safety and scalability across regions
Engage globally through regular international travel, including quarterly leadership meetings in North America, Germany and Brazil, and visits to manufacturing facilities worldwide to stay closely connected to regional complexities and opportunities

What we offer

To be a part of exciting and growing business
Global scope, real ownership and decision-making authority

New

Boutique manager - Nespresso Devonshire Mall

We are seeking a visionary Boutique Manager to spearhead the Nespresso brand-new...

Location

Canada , Windsor

Salary:

72000.00 - 80000.00 CAD / Year

Randstad

Expiration Date

June 08, 2026

Requirements

5+ Years of High-Volume Retail Management
the luxury retail space is an asset Demonstrated ability to prioritize and plan multiple priorities
Strong team-building skills with a history of effective team coaching and development
Effective time management, communication, problem-solving and analytical skills
Passionate about coffee and sustainability
Experience in the food or coffee space an asset
Ability to stand for an entire working day and to repeatedly lift a maximum of 23 kgs.

Job Responsibility

Achieve with team the daily, weekly, monthly sales and service level targets set for the boutique
Maximize guest frequency, sales and acquisition of new club members in the boutique
Maximize capsule, accessories and machines sales in the boutique
Maintain current and up to date knowledge on coffee and the Nespresso product
Continuously evaluate the quality of service and give individual feedback to the Boutique Specialists
Drive the implementation of company programs by motivating and instructing the team to meet operational and organizational objectives
Motivate and coach team to provide exceptional customer service in keeping with our brand image
Plan, identify, communicate and delegate appropriate responsibilities to team to ensure a smooth operation
Provide coaching and direction to the team in an effort to achieve operational goals. Consistently review KPI’s to identify problems, concerns and opportunities for improvements. Create action plan to achieve goals
Monitor and manage staffing levels to ensure boutique operations and customer service goals are met

What we offer

Competitive salary 72,000$ - 80,000$ + quarterly bonus
Comprehensive total rewards benefits package including health and dental benefits that start on day one (including massage, pension plan with employer’s contribution, mental health coverage and Health Spending Account)
Lifestyle spending Account
Free coffee machine & monthly Nespresso credit
Exclusive employee discounts
Excellent training and development programs
Growth opportunities
Free unlimited coffee during working shifts
Pension plan with competitive employer contributions

Fulltime

New

Senior Solution Architect

We are seeking a skilled Solution Architect to design high-quality, scalable, an...

Location

India , Pune

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

11+ yrs expereince & Proficient in architecture and design patterns, with experience in web-based and service-based architectures (REST/SOAP)
Skilled in AWS and cloud-based technologies
Experienced in JavaScript, Node.js, and Spring Boot
Knowledge of authentication standards such as OAuth 2.0, OpenID Connect, WebAuthn, and token management (advantageous)
Strong understanding of web/mobile architecture, microservices, and scalable distributed systems
Hands-on experience in designing, developing, testing, and deploying REST and SOAP APIs
Familiar with continuous integration and test-driven development methodologies
Collaborative team player with experience guiding agile delivery teams
Capable of analysing business requirements and converting them into technical solutions
Graduate in Computer Science or Engineering

Job Responsibility

Develop high-standard solution designs that align with business requirements and technology best practices
Collaborate with local market stakeholders to understand demand and create tailored solutions
Engage with internal architecture communities to ensure alignment, consistency, and compliance
Contribute to and review Low Level Designs (LLDs) in partnership with the Lead Developer
Translate commercial and functional requirements into scalable technical architectures
Take accountability for all releases, delivery timelines, solution reliability, and performance KPIs
Guide and mentor cross-functional agile teams toward optimal implementation
Evaluate and recommend third-party tools and current best practices for inclusion in solution designs

What we offer

Opportunity to work on large-scale, high-impact digital architecture initiatives
Exposure to global stakeholders across multiple markets and technology communities
Ability to influence technical direction, design principles, and best practices within VOIS
Professional growth by leading solution architecture and guiding agile teams

Director, Global Supplier and External Manufacturing Quality

Alfasigma

Location:

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 01, 2026

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