ISO Quality Compliance Manager Job at Translation Empire (Rawalpindi)

Manager, Compliance Quality Systems

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Academic background: Quality, Industrial, Chemical, Biomedical or related Engineering
Experience: 10+ years in Quality roles, with at least 5 in leadership positions
Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry
In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others)
Technical skills: Process engineering, validations and quality controls
Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA)
Audit and regulatory compliance management
Proficiency in oral and written English
Leadership proficiencies: Inspiring and focused leadership
Effective communication and collaborator management

Job Responsibility

Quality System Management: Ensure the establishment, maintenance and improvement of a quality system that meets regulatory, normative and corporate requirements
Approve local specifications and procedures as a Quality Representative
Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies
Risk Management and Compliance: Implement strategies to identify, assess, and mitigate quality risks in processes, equipment and materials
To control the accurate administration of the material and human resources required for compliance with processes
Technical and Business Leadership: Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards
Promote improvement, simplification, innovation and consistency to regulatory standards projects
Represent the Director of Quality in their absence and in strategic committees
People Management and Talent Development: Build and complete development and training plans for the members of the department passionate about Quality
Ensure the continuous training and development of the teams responsible for Quality Engineering

What we offer

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

Manager, Compliance Quality Systems

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Quality, Industrial, Chemical, Biomedical or related Engineering
10+ years in Quality roles, with at least 5 in leadership positions
Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry
In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others)
Process engineering, validations and quality controls
Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA)
Audit and regulatory compliance management
Proficiency in oral and written English
Inspiring and focused leadership
Effective communication and collaborator management

Job Responsibility

Quality System Management: Ensure the establishment, maintenance and improvement of a quality system that meets regulatory, normative and corporate requirements
Approve local specifications and procedures as a Quality Representative
Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies
Risk Management and Compliance: Implement strategies to identify, assess, and mitigate quality risks in processes, equipment and materials
To control the accurate administration of the material and human resources required for compliance with processes
Technical and Business Leadership: Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards
Promote improvement, simplification, innovation and consistency to regulatory standards projects
Represent the Director of Quality in their absence and in strategic committees
People Management and Talent Development: Build and complete development and training plans for the members of the department
Ensure the continuous training and development of the teams responsible for Quality Engineering

What we offer

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

Compliance and Quality Manager

Location

United Kingdom , Leeds

Salary:

65000.00 - 70000.00 GBP / Year

Morson Talent

Expiration Date

Until further notice

Requirements

Significant experience in a rail, construction, engineering, or infrastructure environment
Strong working knowledge of ISO 9001, ISO 45001, and ISO 14001
Experience managing RISQS audits and accreditations
Proven experience leading audits and managing corrective actions
Strong understanding of legislative and regulatory compliance
Excellent stakeholder management and communication skills
Lead Auditor qualification
Experience with Network Rail standards and assurance processes
Experience supporting Principal Contractor duties
Familiarity with Sentinel / rail assurance systems

Job Responsibility

Lead and manage all ISO certification activities, including ISO 9001 (Quality), ISO 45001 (Health & Safety), and ISO 14001 (Environmental), ensuring ongoing compliance and successful external certification audits
Act as the primary point of contact for RISQS accreditation, including audit preparation, evidence management, corrective actions, and continuous improvement
Manage and maintain compliance with the Principal Contractor's Licence and associated assurance requirements
Develop, maintain, and deliver a risk based audit programme, including: Internal audits, Supplier audits, System and process audits
Plan, manage, and maintain the annual audit schedule, ensuring audits are completed on time and actions are tracked to closure
Lead the investigation, management, and close out of Non Conformances (NCRs), including root cause analysis and verification of corrective actions
Support continuous improvement through audit findings, trends, and lessons learned
Create, review, and approve Project Quality Management Plans (QMPs) to support safe, compliant project delivery
Provide quality and compliance support to operational teams during project planning and execution
Ensure quality requirements are embedded into project lifecycle processes

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

ISO Quality Assurance Manager

Location

Pakistan , Rawalpindi

Salary:

Not provided

Translation Empire

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Quality Management, Business Administration, or a related field
Relevant certifications in ISO standards (e.g., Lead Auditor / Implementor ISO 9001:2015, 22301, 45001, 14001) are highly preferred
4+ years of progressive experience in implementing and managing QMS, preferably across ISO 9001, 22301, 14001, and 45001 standards
Expertise in interpreting ISO standards and their practical application within diverse organizational contexts
Proven track record in conducting internal and external audits, and managing certification processes
Strong analytical skills with the ability to assess complex processes and drive improvements
Excellent communication, leadership, and stakeholder management skills

Job Responsibility

Lead the development, implementation, and maintenance of Integrated Management Systems (IMS) compliant with ISO 9001, ISO 22301, ISO 14001, and ISO 45001 standards
Ensure the quality, business continuity, environmental, health and safety processes align with ISO 9001, 22301, 14001 and 45001 standards including other applicable regulations
Develop and refine policies, procedures, and guidelines aligned with ISO standards to ensure compliance and efficiency in operations
Identify opportunities for improvement within the IMS and drive initiatives to enhance operational efficiency and compliance
Conduct risk assessments and implement strategies to mitigate risks associated with quality, continuity, environment, and occupational health and safety
Communicate and ensure adherence to all the ISO standards and integrated management system across the organization
Implement corrective and preventive actions and ensure accurate and timely reporting to regulatory authorities
Develop and maintain change control, business continuity, incident response, disaster recovery and crisis management plans and procedures
Conduct regular drills and exercises to test the effectiveness of the quality control, health and safety, environmental, continuity and recovery plans
Provide training and guidance to employees to ensure awareness and understanding of ISO standards and their application within the organization

Fulltime

Qa Sr Manager External Supply Quality (Esq) - Supplier Quality Management

In this vital role you will serve as the quality lead and subject matter expert ...

Location

United States , Charlotte; Providence; Boston; Los Angeles

Salary:

144021.45 - 194852.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR Bachelor’s degree and 8 years of Quality experience OR Master’s degree and 6 years of Quality experience OR Doctorate degree and 2 years of Quality 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
Educational background in Life Sciences
Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
Relevant work experience within Drug Substance and Drug Product operations, ideally with single use systems and platforms
5+ years of experience overseeing quality of suppliers
Robust problem-solving and root-cause analysis experience
Strong continuous improvement mentality
Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior

Job Responsibility

Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement
Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations
Review and approve quality documentation, including Quality Agreements, deviations, supplier investigations, CAPAs, CAPA EVs, supplier change notifications and change controls, with a sharp eye for risk and compliance
Participate in and/or lead supplier audits and collaborate with internal and external partners to implement corrective and preventive actions
Prepare Amgen sites and suppliers for audits and inspections including development of inspection playbooks
Represent Amgen/ESQ during such audits and inspections - owning our quality story with confidence and clarity
Identify and mitigate risks at the supplier and/or escalate to management
Perform Person in Plant activities, as deemed appropriate
Drive audit commitments to completion
Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions

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

New

Sr Manager, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

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
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

Fulltime

New

Sr. Compliance Quality Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices
Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI)
Validated experience in auditing systems and certification as an Internal Auditor
Knowledge and experience in Sterility Assurance
University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career
Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry

Job Responsibility

Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums
Implement the Internal Audit Program and follow up on corrective and preventive actions
Assess the regulatory alignment of processes and systems
Ensure they follow applicable directives and standards
Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements
Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes
Facilitate root cause analysis and ensure complete documentation in CAPA processes
Implement and maintain the risk system, assessing and controlling risks and leading residual risk
Ensure the accurate execution of the Hold process and the corrective field actions (FCA)
Maintain effective communication with productive areas and lead actions to reduce complaints

What we offer

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

Fulltime

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ISO Quality Compliance Manager

Job Description

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