Quality Control and Compliance Job at Beacon Hill (Washington)

Deputy Director of Quality Assurance and Quality Control

This position provides a high level of responsible, complex management and polic...

Location

United States , Honolulu

Salary:

120900.00 - 193490.00 USD / Year

Honolulu

Expiration Date

Until further notice

Requirements

A combination of education and experience substantially equivalent to graduation from an accredited college or university with major work in quality management, business administration, engineering, or a related field
five years of progressive experience in quality assurance, quality control, or related administrative or analytical field
experience must include active involvement in developing, implementing, improving QA/QC processes or programs, with demonstrated ability to analyze operations and develop effective solutions
a minimum of two years experience in a governmental agency or regulated industry, including experience supervising or managing QA/QC activities or teams
candidate must meet the health and physical condition standards necessary and proper for performing the essential duties

Job Responsibility

Assist, establish, implement, and maintain an effective Quality Management Plan for HART, including methods to investigate, monitor, regulate, and enforce quality standards
establish coordination of functions and operations across departments through the development and clear definition of quality assurance procedures
ensure HART’s compliance with applicable laws, regulations, rules, and generally accepted industry practices
provide additional oversight for the planning, analysis, inspection, design, testing, and/or integration of products and/or components to ensure compliance with HART’s quality assurance program
contribute to the development of contractor and quality specifications for design, procurement, and construction contracts
oversee internal and external audit, surveillance, and monitoring programs, ensuring compliance with HART's requirements
holds the delegated responsibility for ensuring that internal and external audits are scheduled, performed, and followed up
review HART’s activities, including contract work performed
help to identify and evaluate quality issues or work deficiencies, and initiate, recommend, or implement solutions and procedural changes as needed
guide and direct other quality assurance functions, including the conduct of quality engineering reviews of design plans, specifications, procedures, contracts, and request for proposals, for completeness and quality requirements

What we offer

Medical, prescription drug, vision, dental, and life insurance plans
generous vacation and sick leave, earning up to 21 days per year
13 paid holidays annually (14 days during election year)
retirement plan contributions through the Employees' Retirement System (ERS)
deferred compensation options to invest pre-tax income for retirement
flexible spending accounts for health and dependent care expenses
pre-tax transportation benefits, including TheBus and vanpool options
access to confidential counseling services through the Employee Assistance Program (EAP)
additional perks include training opportunities and employer-funded Holo Card for eligible employees to use on public transit
eligibility for Public Service Loan Forgiveness (PSLF) program, supporting employees dedicated to public service

Fulltime

Vice President (VP), Issue Quality Control and Engagements Lead

The Vice President (VP), Issue Quality Control and Engagements Lead will be resp...

Location

United Kingdom , Belfast

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Minimum of 6-10 years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry
Ability to identify, measure, and manage key risks and controls
Strong knowledge in the development and execution for controls
Proven experience in control related functions in the financial industry
Proven experience in implementing sustainable solutions and improving processes
Understanding of compliance laws, rules, regulations, and best practices
Understanding of Citi's Policies, Standards, and Procedures
Strong analytical skills to evaluate complex risk and control activities and processes
Strong verbal and written communication skills, with a demonstrated ability to engage at the senior management level
Strong problem-solving and decision-making skills

Job Responsibility

Execute Quality Control activities across the full issue lifecycle in line with Issue Management, Quality Controls, and where required Quality Assurance procedures
Assess issue pervasiveness, challenge severity, impact and navigate management in the drafting of risk driven observations
Challenge Management's proposed remediation approach ensuring that it addresses root causes, it is sustainable and adheres to external (regulatory) & internal (policy) requirements
Support key stakeholders in the design and development of corrective action plans to address identified control gaps or failures
Leverage lessons learned from prior IQC reviews to improve the quality of remediation & timely closure of issues
Establish a network of key stakeholders in control functions to enable effective collaboration and partnership during engagements
Engage IA, ORM, ICRM, etc. on Audit/Exam scoping, bringing in SMEs as needed, to manage exercise scope
Support the business throughout all phases of the review/exam lifecycle
Create and continuously maintain a comprehensive, centralized view of the progress of planned non-regulatory engagements
Design and deploy reporting capability to ensure effective and timely communication of progress of these engagements

Fulltime

Vice President (VP), Issue Quality Control and Engagements Lead

Location

Costa Rica , Heredia

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Minimum of 6-10 years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry
Ability to identify, measure, and manage key risks and controls
Strong knowledge in the development and execution for controls
Proven experience in control related functions in the financial industry
Proven experience in implementing sustainable solutions and improving processes
Understanding of compliance laws, rules, regulations, and best practices
Understanding of Citi's Policies, Standards, and Procedures
Strong analytical skills to evaluate complex risk and control activities and processes
Strong verbal and written communication skills, with a demonstrated ability to engage at the senior management level
Advanced English Skills required

Job Responsibility

Execute Quality Control activities across the full issue lifecycle in line with Issue Management, Quality Controls, and where required Quality Assurance procedures
Assess issue pervasiveness, challenge severity, impact and navigate management in the drafting of risk driven observations
Challenge Management's proposed remediation approach ensuring that it addresses root causes, it is sustainable and adheres to external (regulatory) & internal (policy) requirements
Support key stakeholders in the design and development of corrective action plans to address identified control gaps or failures
Leverage lessons learned from prior IQC reviews to improve the quality of remediation & timely closure of issues
Establish a network of key stakeholders in control functions to enable effective collaboration and partnership during engagements
Engage IA, ORM, ICRM, etc. on Audit/Exam scoping, bringing in SMEs as needed, to manage exercise scope
get business de-scoped where it makes sense
Support the business throughout all phases of the review/exam lifecycle by: advising on scope determination, advising business/function on the drafting of responses to optimize for positive outcomes
challenging response drafts for adequacy before submitted back

Fulltime

Flex manager, Data Quality and Compliance Operations

Responsible for executing and managing data quality and compliance operations su...

Location

United States , Bethesda

Salary:

46.15 - 75.91 USD / Hour

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, Information Systems, Accounting, or a related field
Minimum of 5 years of experience in data quality, compliance operations, SOX, or audit support roles
Strong understanding of data quality principles, control frameworks, and regulatory compliance
Hands-on experience with data governance, data quality, or compliance tools
Excellent analytical, communication, and stakeholder coordination skills

Job Responsibility

Execute and manage SOX and SCOUT data-related controls, including documentation, testing, and remediation
Monitor data quality controls for accuracy, completeness, and timeliness across critical datasets
Coordinate audit evidence collection and serve as the operational point of contact for Finance and Audit partners
Lead root-cause analysis and corrective actions for data quality or compliance issues
Maintain operational artifacts such as control narratives, SOPs, and runbooks
Track and report on compliance KPIs, SLAs, and issue remediation status
Utilize and support administration of data governance and compliance technology platforms
Collaborate with IT, Data Engineering, Finance, and Risk teams to embed compliance into daily operations
Lead and mentor analysts or contractors supporting compliance and data quality operations

What we offer

401(k) plan
stock purchase plan
discounts at Marriott properties
commuter benefits
employee assistance plan
childcare discounts
medical
dental
vision
health care flexible spending account

Fulltime

Quality and Compliance Manager

The Quality and Compliance Manager (EMEA Sub-Regional lead) provides quality sup...

Location

Belgium , Antwerp

Salary:

Not provided

JLL

Expiration Date

Until further notice

Requirements

BSc degree in life science, engineering or equivalent
Minimum of five (5) years of experience in quality and/or compliance in engineering, facilities management, production, operations, lab operations or equivalent
Prior experience working in a GMP environment preferably in pharmaceutical and/or biotechnology
Experience leading investigations, change control, root cause analysis (RCAs) and CAPAs in a regulated environment
Experience in supplier management in GxP environment
Strong leadership experience and experience interacting at all levels
Strong knowledge and understanding of Quality Management Systems (ISO 9001, ISO 13485 and/or GMP) and EMEA cGxP standards and regulations in Pharmaceuticals and/or MedTech
Ability to communicate effectively in oral and written reports
Good customer service skills and relationship building skills
Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision

Job Responsibility

Support the implementation and maintenance of the JLL ISO 9001 QMS and cGxP requirements on the account
Support the implementation and maintenance of the account Quality Management Plan (QMP)
Serve as the account quality contact and subject matter expert (SME) in the sub-region
Support the implementation and maintenance of the Quality Agreement between JLL and the client for sub-region and/or sites in their scope
Ensure training compliance in sub-region or sites in scope, through document reviews, self-assessments, audits, etc.
Support the implement Quality and Compliance programs on the account, to ensure sustainability of service quality
Prepare and manage quality documentation e.g. SOPs, change control documentation, quality agreements, training materials, investigations, CAPA, etc.
Lead and support JLL quality related complaints, change controls, deviations, investigations, root cause analysis (RCAs) and CAPAs in sub-region or sites in their scope
Perform qualification of cGxP impacting vendors, establish quality agreements, conduct vendor quality performance reviews and maintain the account approved supplier list (ASL)
Interface and represent JLL with the client FM teams and reporting of regional KPIs on a monthly basis

Fulltime

Quality and Compliance Manager

The Quality & Compliance Manager oversees quality assurance operations for JLL's...

Location

United States , Summit, NJ; Warren, NJ

Salary:

95000.00 - 115000.00 USD / Year

JLL

Expiration Date

Until further notice

Requirements

Bachelor's degree in Science or Engineering
Minimum 3 years of experience in quality engineering, facilities operations, or production operations in a cGMP environment
Prior experience working in an FDA-regulated bio-pharmaceutical manufacturing facility
Knowledge of FDA regulations 21 CFR Parts 210, 211, or Part 820
Understanding of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
Experience with quality management systems including investigations, CAPAs, audit programs, and vendor qualification
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Candidates must be authorized to work in the United States without sponsorship

Job Responsibility

Oversee regulatory and quality compliance activities across all facilities team operations and subcontractors
Prepare, review, and manage SOPs, quality investigations, deviations, CAPAs, and change control documentation
Interface with client quality organization to ensure adherence to all quality procedures and proper work documentation
Manage GxP contractor compliance programs including qualification, agreements, audits, and performance monitoring
Conduct quality audits and assessments of building systems such as HVAC, critical environments, and utilities
Collaborate with maintenance teams to support quality investigations and root cause analysis
Provide quality guidance and training to facilities staff, vendors, and service providers
Monitor and report on Key Performance Indicators and Service Level Agreement compliance
Review and approve technical documentation and quality reports for client delivery
Support continuous improvement initiatives and quality system enhancements

What we offer

401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
Early access to earned wages through Daily Pay

Fulltime

Inventory Control and Quality Assurance Manager Supply Chain

The Inventory Control and Quality Assurance (ICQA) Manager ensures the accuracy ...

Location

United States , Minneapolis

Salary:

74252.00 - 87725.00 USD / Year

Alliance Automotive UK LV Ltd

Expiration Date

Until further notice

Requirements

2+ years’ experience working in quality assurance, inventory control and/or customer service within a distribution center or similar environment
1+ year’s proven experience in a managerial role and/or leading teams
Ability to motivate and inspire a team to actively contribute to problem-solving and continuous improvement initiatives
Excellent organizational and problem-solving abilities, with a keen attention to detail and a proactive approach to addressing challenges
Familiarity with warehouse operations and logistics software (e.g., WMS, ERP systems)
Ability to thrive in a fast-paced environment and adapt to changing priorities
Strong communication skills, both verbal and written
Commitment to upholding high standards of integrity, professionalism and customer service, with a focus on supporting team members and delivering for customers

Job Responsibility

Provides and supports the implementation of business solutions and ensures compliance with policies and procedures focused on quality assurance
Ensures accuracy of inventory counts and quality, as well as quality of outbound shipments
Leads the ICQA team to collaborate with DC management on process improvement and value enhancement opportunities
Contributes to new business initiatives and projects
Manages the root cause analysis and corrective actions for quality issues
Manages inventory profiles throughout the warehouse
Reviews and evaluates quality data to identify process improvement opportunities
Creates corrective action plans to address process failures
Utilizes techniques for continuous improvement including Lean, Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)
Monitors and reports on supplier product quality and performance

What we offer

Health Insurance: Comprehensive medical, dental, and vision plans
Retirement Plan: 401(k) with company match
Paid Time Off: Vacation, personal days, holidays, sick days, and paternal leave
Additional Perks: Employee stock purchase plan, tuition reimbursement, professional development opportunities, and wellness programs

Fulltime

Associate Director, Analytical Development and Quality Control

The Associate Director, Analytical Development and Quality Control will support ...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience, or 5+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis
Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
Strong track record of working with CROs/CMOs and managing external analytical/testing activities
Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
Demonstrated leadership ability with experience mentoring and developing scientific staff
Strong communication, cross-functional collaboration, and project-management skills
Innovative team-player with high energy for our dynamic company environment

Job Responsibility

Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
Support comparability assessments for process changes, analytical method updates, or site transfers
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

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