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

Supplier Quality Development Manager

The Supplier Quality Development Manager (SQDM) develops, implements, leads and ...

Location

United States , Seneca

Salary:

125600.00 - 172700.00 USD / Year

BorgWarner

Expiration Date

Until further notice

Requirements

Bachelor's degree in engineering or technical field (e.g. Mechanical, Industrial, Production technology) with solid technical background
7+ years of professional experience in Quality, Production, Logistics, Cost/Process Planning
Strong communication skills, team player, comprehensive thinking, management skills and highly flexible
Commodity experience required
7+ years Supply Management experience working in Automotive Production environment preferred
Increasing responsibility in an automotive production environment
Proven record in Manufacturing, Supplier Quality and Process Improvement initiatives
Demonstrated competence in negotiating skills and assessing vendors
Fluency in English and Foreign Language preferred
Excellent Quality Orientation

Job Responsibility

Create, execute, communicate and maintain supplier quality strategy for commodities
Manage a team of direct reports to facilitate execution of supplier quality goals and objectives
Coordinates the Supplier Quality Managment Engineers (SQME) activities for New Product Development and/or changes related to current products
Create and implement Supplier Vetting Strategy, Supplier Capability Assessment, Supplier Selection (Pre-Sourcing) and Development Strategy, and Key Supplier Performance Metrics
In collaboration with Global Supply Management Manager and Quality Director, develop and implement supplier quality roadmap
Create and implement global commodity quality requirements
Benchmark suppliers on Best in Commodity production strategies
Identify new technologies that support BorgWarner's growth and product leadership position in the market
Identify and develop Suppliers that meet and/or exceed BorgWarner long-term expectations that result in a differentiation in the marketplace
Create supplier quality vetting strategies

Fulltime

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

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

Automation Manager

Responsible for the planning, implementation, operation, maintenance, optimizati...

Location

China , Shanghai

Salary:

450000.00 - 550000.00 CNY / Year

Randstad

Expiration Date

June 17, 2026

Requirements

Bachelor's degree or above in Automation, Electrical Engineering and Automation, Measurement and Control Technology and Instruments, Process Equipment and Control Engineering, or related majors
master’s degree preferred
Prior experience in foreign-invested pharmaceutical manufacturing enterprises preferred
familiarity with GMP and other compliance requirements in the pharmaceutical industry
experience in automation management in pharmaceutical facilities highly preferred
5-8+ years of experience in automation-related fields, including 3+ years in team management
experience in managing automation teams in pharmaceutical facilities preferred
Hands-on experience in O&M, optimization, and project management of automation systems (PLC, SCADA, MES, DCS, etc.)
experience in implementing automation projects on pharmaceutical production lines preferred
Experience participating in external regulatory inspections (NMPA, etc.) and internal audits

Job Responsibility

Responsible for the full lifecycle management of all automated equipment and control systems (such as PLC, SCADA, MES, DCS, BMS, EMS, etc.)
Ensure automation systems meet data integrity regulatory requirements
establish SOPs for routine data integrity maintenance
Develop daily operation and maintenance management systems, safety operating procedures, and emergency response plans for automation systems
Responsible for compliance management of automation systems
coordinate with internal audits and external regulatory inspections (EMEA, PIC/S, NMPA, etc.)
Responsible for the overall management of automation-related projects (such as automation setup for new production lines, upgrade and renovation of existing systems, introduction of intelligent equipment, etc.)
Monitor trends in automation and intelligent technologies in the pharmaceutical industry
propose optimization and upgrade recommendations for automation systems
Collaborate with Production, Quality Control, and Warehousing departments to optimize automation processes

Fulltime

Site Director

The Site Director has full oversight for delivering manufactured drug products t...

Location

United States , Round Lake

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

10+ years' of progressing experience in manufacturing function(s), and 4+ years in a plant leadership role, preferably within medical device or pharmaceutical manufacturing
Required BS/BA in Engineering, Operations Management or related degree, an advanced degree is a plus
Proven experience applying Lean principles and methodologies (e.g. Kaizen, 6S, Value Stream Mapping) to drive process improvement and operational efficiency, with a track record of identifying waste and continuous improvement execution
Ability to make accurate trade-offs to balance operational execution across production, quality, safety, customer delivery and financial metrics
Interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Responsible for meeting or exceeding plant financial goals and key operating performance targets on a monthly, quarterly, and annual basis
Drive continuous improvement of site operations through a formal program, resources, metrics, and accountability
Report on operational performance monthly and take actions to address misses. Establish communication operation mechanism to keep senior leadership informed of both leading and lagging performance and act to address
Build a culture within the plant to maintain compliance with EH&S and external regulatory requirements, for a zero-harm workplace
Interact regularly with senior management on matters concerning functional areas and/or customers. Frequently interact with other plant managers and technology groups within the Corporation and contract vendors outside the Corporation
Develop and own three-year site capital plan and drive execution to support ongoing business as well as expansion opportunities
Liaise with Global Procurement for optimization of raw material suppliers, supplier score card measures and action plans, and cost reduction goals. Liaise with R&D to support new product development plans and ensure adequate support of NPD program to achieve target launch dates

What we offer

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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

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Director, Global Supplier and External Manufacturing Quality

Job Description

Job Responsibility

Requirements

What we offer

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