Senior Quality Manager – Regulatory Surveillance Job at Connexion Systems & Engineering, Inc (Boston)

Senior Quality Manager – Regulatory Surveillance

We are seeking a self-starting, dynamic Senior Quality Manager to lead regulator...

Location

United States , Boston

Salary:

75.00 - 82.75 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, operations research, operations management, or related field
Typically 6+ years of relevant experience or equivalent combination of education and experience
Strong facilitation, organization, communication, and influencing skills
In-depth knowledge of global GMP requirements and regulations
Ability to evaluate quality matters and make risk-based decisions
Proven ability to identify and analyze performance indicators
Technical expertise in regulatory compliance, inspections, and quality systems

Job Responsibility

Triage and assess regulatory surveillance items, including new regulations and guidance
Lead cross-functional teams to evaluate the impact of regulations on quality systems and processes
Provide guidance on regulatory expectations, standard industry practices, and implementation options
Support inspection and submission readiness by tracking, reporting, and communicating progress
Present KPIs and metrics to stakeholders to highlight status, risks, and performance

Fulltime

New

Quality Manager

This Quality Manager role offers the opportunity to support a major capital proj...

Location

United States , Houston

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, quality management, construction management, or a related technical discipline
equivalent relevant industry experience may be considered
Strong working knowledge of ISO 9001 quality management principles and their practical application within complex capital projects, EPC delivery models, and contractor assurance programs
10+ years of progressive experience in engineering, construction, fabrication, procurement, or EPC project environments, including significant experience in senior project quality assurance leadership roles
Demonstrated experience establishing and overseeing quality assurance programs across multiple project phases, including engineering, procurement, fabrication, construction, commissioning/readiness, and decommissioning or closeout
Proven ability to lead audits, surveillance activities, non-conformance management, corrective action programs, root cause analysis, and continuous improvement initiatives across contractors and suppliers
Strong interface management, communication, and influencing skills with the ability to engage effectively with project leadership, technical disciplines, contractor quality representatives, and customer stakeholders
Ability to lead quality workshops, provide coaching and training, and promote a strong quality culture that supports disciplined execution, compliance, and continuous improvement
ISO 9001 Lead Auditor
Certified Quality Auditor

Job Responsibility

Develop, implement, and maintain the Project Quality Assurance Strategy, Quality Plan, and Project Assurance Program
Provide independent oversight of project execution to verify that work processes, deliverables, and records conform to regulatory, contractual, and project-specific quality requirements
Lead and coordinate quality activities across Facilities, engineering, procurement, fabrication, construction, and decommissioning scopes
Direct the effective implementation of quality assurance requirements by EPC contractors, third-party contractors, suppliers, and subcontractors
Conduct and coordinate quality audits, assessments, surveillances, and spot checks to evaluate conformance, effectiveness, and risk
Implement, monitor, analyze, and report project quality KPIs, trends, and performance insights to project leadership
Lead resolution of quality concerns, including non-conformances, audit findings, and corrective action plans
Drive continuous improvement through root cause analysis, lessons learned, and systemic improvement actions
Establish and lead the project-wide independent assurance program, including a risk-based schedule of audits, assessments, surveillance activities, and compliance reviews
Verify the adequacy and effectiveness of the Project Quality Management System and supporting contractor quality systems

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Senior Regulatory Affairs Specialist – Regional

This role offers an exciting opportunity to provide regional regulatory support ...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Pharmacy, Science, or equivalent
Minimum 6 years of regulatory experience in the medical devices industry
Strong expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above
In‑depth knowledge of regulatory laws, acts, and evolving requirements
Solid understanding of GDPMD standards
Skilled in project management, multitasking, and prioritization
Excellent interpersonal, communication, and negotiation skills
Proficiency in technical systems (word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate effectively

Job Responsibility

Develop and execute regulatory project plans that keep products moving efficiently through approval pathways
Identify and escalate regulatory risks early, ensuring proactive solutions
Stay ahead of evolving regulations and translate requirements into clear, actionable steps
Maintain accurate and compliant regulatory files and documentation
Actively contribute to project teams, offering practical regulatory guidance
Respond to inquiries from regulatory authorities within strict timelines
Compile, prepare, and submit new registrations, variations, renewals, and change notifications to secure timely approvals
Review and approve labeling and promotional materials to ensure compliance with local regulations
Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards
Manage post‑market surveillance (PMS), field actions, and complaints in Singapore and Malaysia

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Senior Manager, Manufacturing Operations

The Senior Manager of Manufacturing Operations is responsible for driving and su...

Location

United States , Rockville, Maryland

Salary:

113000.00 - 126000.00 USD / Year

Antech Diagnostics

Expiration Date

Until further notice

Requirements

MS degree in Biological Science or Biochemistry/Immunology
Minimum 10 years’ experience working in a regulated manufacturing environment
Project Management experience
Must have good understanding of diagnostic product manufacturing and operations
Experience with quality systems for diagnostic products (or other related, regulated manufacturing operations)
Experience interacting with regulatory agencies including audits, import/export, post-market surveillance, permitting, etc.
Ability to think strategically to align and identify needs with incoming portfolio opportunities
Flexibility to be able to work in a cross-functional, multi-disciplinary environment
Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, interdisciplinary team-based environment
Strong commitment to product quality and continuous improvement

Job Responsibility

Responsible for overall operational execution including, but not limited to, planning, scheduling, manufacturing, warehouse, and facility operations with a focus on quality, availability, inventory controls/system and manufacturing costs
Lead and drive the successful execution of Operational, Manufacturing and Quality initiatives in conjunction with strategic business plans
Provide regular project status information to team members, including preparing project plans, scheduling and attending required meetings, and following up on action items
Develop and implement effective and strategic business solutions through research and analysis of data and business processes
Develop or assist in the development of work plans and task sequencing
Develop or assist in the development of training materials and training records for staff
Serve as a resource for internal team members for expedited problem identification and resolution, provision of project-specific updates, and team interactions and deadlines
Maintain all relevant documentation and communications to support goals
Manage resources and prioritize responsibilities as aligned with business needs to include running the business activities, project support, and continuous improvement activities
Creation of processes for operational efficiencies including planning and MRP control systems

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

Fulltime

Manager, Quality Management System

As the leader of our Quality Management System at Archer, you will play a pivota...

Location

United States , San Jose

Salary:

117500.00 - 155600.00 USD / Year

Archer Aviation

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering (Aerospace, Mechanical, Electrical, or Industrial) with at least 7+ years’ experience leading quality teams within aerospace or other regulated industry
Experience hiring, leading and managing salaried & hourly employees
Experience overseeing and implementing AS9100 certification with an in-depth understanding of AS9102, AS9103, and AS9145
Direct experience establishing and leading CABs and supporting MOR quality reviews with senior leadership
Experience leading all aspects of quality to include: QMS (Quality Management System)
Auditing (Internal & External)
3rd Party Certification, Receiving Inspection
In-Process Inspection
Product Quality Engineering
FMEA (Failure Mode Effects Analysis) implementation

Job Responsibility

Author, maintain, and continuously improve the QMS (Quality Manual, procedures, work instructions) ensuring full compliance with AS9100 and FAA 14 CFR § 21.137 Quality System requirements across all Archer sites
Serve as the primary quality liaison with the FAA during Production Certification, supporting conformity inspections, and airworthiness certificate issuance activities
Establish and govern a unified QMS framework across multiple sites, including standardized audit programs, cross-site corrective action processes, and site-level quality leadership structures
Lead internal and external audits with AS9100 third-party certification body and FAA surveillance audits across all sites
Own the Corrective Action Board (CAB) and Root Cause Corrective Action (RCCA) process to drive systemic resolution of nonconformances across all sites
Define and report KPIs to senior leadership via Monthly Operations Reviews (MOR) and real-time dashboards
Integrate quality into Engineering, Manufacturing, Supply Chain, and Flight Operations processes
Partner with Archer Certification and Safety Department on SMS and Type Certificate obligations
Manage QMS budget and a geographically dispersed quality team

Fulltime

Senior Manager, Security Operations

The Senior Manager of Physical Security owns the strategy, architecture, impleme...

Location

United States , Denver

Salary:

150000.00 - 175000.00 USD / Year

Rowan Digital Infrastructure

Expiration Date

Until further notice

Requirements

10+ years of progressive experience in physical security leadership
5+ years in mission-critical or high-security environments (data centers, utilities, defense, or similar)
Demonstrated experience designing and deploying enterprise-scale access control and video systems
Experience managing multi-site or campus-scale security operations
Contractor and vendor management experience
Strong understanding of layered security architecture and CPTED principles
Ability to lead incident response and crisis coordination
Strong technical fluency with networked security systems

Job Responsibility

Lead end-to-end physical security system design for new and existing data center campuses
Develop campus-level security architecture standards
Partner with Engineering, Construction, IT, and Development during design and commissioning phases
Approve shop drawings, submittals, and integration designs from vendors and contractors
Standardize hardware platforms and integration approaches across campuses
Own day-to-day performance of all physical security systems
Establish SLAs and KPIs for uptime, incident response, and system reliability
Lead incident response for physical security events
Oversee badge access governance, permissions, and audit controls
Ensure accurate logging, retention, and evidentiary chain-of-custody procedures

What we offer

Hybrid working environment
Team building and educational opportunities
Generous benefits package including robust health benefits and a 401(k) company contribution
Unlimited PTO
Competitive compensation and bonus plan

Fulltime

Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Moderna is seeking a Senior Product Manager – Clinical Safety and Pharmacovigila...

Location

United States , Cambridge, Massachusetts; Bethesda, Maryland

Salary:

145900.00 - 234200.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Prior 7+ years' experience in the pharmaceutical or biotechnology industry
Strong domain expertise in Pharmacovigilance, including safety case processing, aggregate reporting, and post-marketing surveillance
Demonstrated product management experience delivering technology solutions in a life sciences or healthcare environment
Hands-on experience serving as System Owner for validated GxP systems
Solid working knowledge of GxP, GAMP5, and regulatory expectations for computerized systems supporting safety operations
Familiarity with Argus Safety, Veeva Vault and other PV ecosystem platforms and integrations
Experience working with agile software development teams in a digital product model
Ability to collaborate across time zones and cultures
strong cross-functional communication and influence skills
A mindset focused on curiosity, ownership, and continuous learning, aligned with Moderna Mindsets

Job Responsibility

Serve as System Owner for Clinical Safety and Pharmacovigilance systems, accountable for end-to-end system operations, governance, and lifecycle planning
Manage and continuously improve the release management process, including planning, testing, and deployment of new system features and enhancements
Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, and Regulatory teams
Contribute to the definition and delivery of the product strategy and roadmap in alignment with business needs
Support execution of the roadmap by coordinating initiatives across functions
Support the evaluation and implementation of innovative capabilities such as AI/ML to enhance safety operations
Collaborate with agile software squads to develop and deliver custom features and scalable solutions supporting safety operations
Contribute domain knowledge to adjacent systems and processes, including regulatory information management and quality compliance systems
Proactively challenge existing solutions and workflows, identifying opportunities for simplification, optimization, and innovation
Operate effectively in a global, cross-timezone team environment with colleagues and partners in the U.S., Poland, and India

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
annual discretionary bonus
other incentive compensation
equity award

Fulltime

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Senior Quality Manager – Regulatory Surveillance

Job Description

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Senior Quality Manager – Regulatory Surveillance

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