Quality & Compliance Manager Job Description
Quality & compliance manager
provides support in Quality & environmental management - ISO 9001 & ISO 14001 – systems and safety management systems.
Quality & Compliance Manager Duties & Responsibilities
To write an effective quality & compliance manager job description, begin by listing detailed duties, responsibilities and expectations. We have included quality & compliance manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Identify and implement effective quality systems at the FG/EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Execute against established internal audit procedures
Provides management and tactical direction for the global Quality Systems and Compliance functions
Establishes and maintains policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) all other applicable global regulatory requirements
Ensures our global quality systems strategy adds value to the organization through risk reduction, cost improvement and budgetary responsibility
Assesses/modifies quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required
Identify and document processes and develop standard operating procedures (SOP's) or Best Practice Documents (BPD's) as required
Support planning and execution of Internal Quality compliance audits and Supplier Audits
Ensure that there are processes in place to monitor and measure all activities related to quality assurance performance improvement
Develop, measure, and report key quality metrics to drive quality and efficiency
Quality & Compliance Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality & Compliance Manager
List any licenses or certifications required by the position: ASQ, ISO, AS9100, CQA, MDSAP, HACCP, OSHA, RAB/QSA/IRCA, SNE, PMP
Education for Quality & Compliance Manager
Typically a job would require a certain level of education.
Employers hiring for the quality & compliance manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Education, Business, Chemistry, Management, Technical, Pharmacy, Medical, Life Sciences
Skills for Quality & Compliance Manager
Desired skills for quality & compliance manager include:
Quality systems
& policies helpful
Procedures
Addition
Algebra and geometry
Basic shop math
Geometric Dimensioning and Tolerancing
Subtraction
ISO 9001
Quality Management Systems
Desired experience for quality & compliance manager includes:
Complete Non-conformances and CAPAs related to FG/EM suppliers and Bridgewater site within required timelines
Establish process model for quality improvement and provides training to organization personnel
Provide effective leadership in supporting quality disciplines, decisions, and practices for Bridgewater site
Directly support Bridgewater Quality management team for activities related to Site Performance Management Review, Audits and site certification
HEDIS Project
Enhance company brand in China
Quality & Compliance Manager Examples
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Quality & Compliance Manager Job Description
Job Description Example
Our growing company is looking for a quality & compliance manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality & compliance manager
- Independently schedule, conduct and report initial, routine and follow up audits of co-packer quality systems
- Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements
- Where appropriate, execute program(s) for training and evaluating qualifications of auditors
- Ensure that business partners are accountable and understand J&J quality system requirements and how they impact product quality and regulatory compliance
- Provide guidance and training to project teams to ensure strategic compliance and quality requirements are met during product development, scale up and validation
- Coordinate new product activities between Business QA, Plant QA and Manufacturing to ensure effective hand-offs and flawless execution of all new product processed and activities resulting in timely and high quality documentation for Approval for Product Release (APR)
- Provide input to risk assessment on new product quality and compliance related issues
- Partner with Internal and External Manufacturing QA and Supplier Quality to ensure that new products and processes are transferred to the manufacturing environment with clear quality plans and robust process capabilities
- Partner with Product Development, Technical Transfer and Manufacturing functions to define the product and process Critical-to-Quality (CTQ) / Critical Process Parameters (CPPs) which establish robustness
- Partner with the Raw Material Center to ensure that all new raw materials are qualified and suppliers have been approved in accordance with J&J requirements
Qualifications for quality & compliance manager
- Results oriented, consumer driven
- Managing the NonGMO project verification program across all business units including bringing on new plants,getting new products approved, maintaining certification of verified plants and completing annual recertification
- Represent Business QA at the New Product Innovation (NPI) Reliability SWAT teams to ensure timely execution of new product development initiatives
- Represent Business QA at the Technical Review Forums (TRF) to ensure that data from all functions are reviewed by a cross-functional team and that potential concerns are addressed prior to production or commercialization
- Represent Business QA at the Innovation Stage Gate Committee (ISGC) to ensure that quality and compliance is addressed during the deployment of new product prior to Commit-to-Trade (CTT)
- Collate data on product and manufacturing process performance quality metrics for reporting to FDA
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Quality & Compliance Manager Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality & compliance manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality & compliance manager
- Lead the successful implementation and closure of all internal and external commitments ensuring all are entered into the AQWA system
- PV Metrics
- PV Training development and training
- Inspection Readiness and Facilitator
- PSMF author and maintenance
- PV CAPA management
- Contract language review
- Case QC on select cases
- Develop knowledge and understanding of the many compliance requirements to be seen as an expert in the field
- Lead SRR monthly calls, training sessions and workshops to ensure the Breeding organization has the proper understanding of compliance, trait quality and quality requirements
Qualifications for quality & compliance manager
- Ensure training and education for the food security team, for the operators to monitor critical points
- Certified Quality Auditor is required
- Capable of working independently part of a cross- functional team demonstrating the ability to influence and create alignment across multiple functional areas
- You have a Bachelor’s Degree in medical or mechanical engineering or in a similar field and a minimum of 8 years of experience in a GMP manufacturing environment
- You are familiar with GMP, ISO 13485, 21 CFR Part 820 standards and you dispose of working knowledge of FMEA, validation programs and SPC processes in a highly regulated environment
- You dispose of excellent leadership skills and have successfully managed a team in a multinational organization
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Quality & Compliance Manager Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality & compliance manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality & compliance manager
- Ensure the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, ISO 9001)
- Lead department activities within the Quality Systems function (i.e., Document and Data Control, Retain and Records Retention, Training, Corrective and Preventive Action, Change Control, Deviation, Supplier Audits, Supplier Corrective Action Requests, Electronic System Development/Validation, Management Review, Risk Management, Auditing, Agency Inspections and Quality Improvement Initiatives)
- Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes
- Work closely with Quality Management to increase communication and leverage Quality Management Systems, assure Stewardship policies and Regulatory requirements are implemented
- Perform Compliance and QMS functions system and processes based audits at Breeding field sites, Pathology locations, and provide candid and constructive feedback to the audited sites/teams
- Work closely with the Quality Management team to increase communication, leverage quality control and management systems, assure stewardship policies and regulatory guidelines are in place
- Participate in operational excellence initiatives, including process and continual improvement, regulatory compliance, trait quality, and other identified initiatives
- Partner with the site teams to perform GAP analyses and build relationships to provide support
- Develop, implement and continuously improve processes of the ongoing co-packer assessment and re-approval program based on risk
- Collation of information supporting continued approval of co-packer and ensuring RB continued confidence in the co-packer to perform at the required standard to supply RB (using a database or similar format)
Qualifications for quality & compliance manager
- You are willing to travel in support of business needs to different geographical locations
- You are fluent in English and have a very good command of German
- A minimum of a Bachelor’s of Science degree + 6 years drug safety or relevant experience
- Strong working knowledge of ARGUS safety database, PV regulations/FDA regulations, ICH guidelines, GVP modules and EU regulations and other relevant global requirements in the post market and clinical trial environment
- Project management skills including management of both time and priority constraints
- Solid expertise in all Microsoft office applications (e.g., Word, Excel, PowerPoint)
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Quality & Compliance Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality & compliance manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality & compliance manager
- Lead IT Compliance function, creating, implementing, supporting and managing the operation of the IT Quality Management System and advising IT and business leaders on Quality standards
- Create and execute scalable and sustainable IT Quality strategy to support business goals
- Foster a culture of quality within the IT team to deliver the continual improvement of IT services provided to the business
- Drive quality and compliance initiatives encompassing Business Leaders and various divisional Quality teams
- Keep current with Regulatory trends and communicate changing requirements to upper management recommending required actions, subsequently realizing needed change to the IT Quality Program
- Ensure IT systems/applications, processes and qualified infrastructure spaces remain compliant with company policy local, federal and foreign (where applicable) regulations
- Ensure regular IT quality reviews are performed to ensure on-going compliance
- Maintain and develop an effective training program for corporate IT employees and contractors who support quality initiatives
- Manage and maintain Corrective and Preventive actions
- Drive Quality Improvements in IT processes through root cause analysis and sustainable corrective actions
Qualifications for quality & compliance manager
- Ability to work under pressure in order to meet tight deadlines and good interpersonal skills (i.e., team player)
- Strong organizational skills/attention to details, and ability to adapt in a fast paced constantly changing environment
- RN, Nurse Practitioner, Physician Assistant or related healthcare experience
- A broad knowledge of Pharmaceutical regulatory compliance best practices
- Good knowledge of medical terminology highly desirable
- Result orientation and excellent organizational and record keeping skills
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Quality & Compliance Manager Job Description
Job Description Example
Our innovative and growing company is hiring for a quality & compliance manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality & compliance manager
- Understands requirements and processes for Best in Class Quality Management Systems
- Leads large cross functional and complex initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems
- Develops and delivers training curriculum and content for Quality Systems processes
- Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen Quality Systems knowledge
- Ensure the accuracy of the regulatory contact and submission log is maintained
- Lead the follow-up, negotiation and resolution of issues regarding current and future submissions with appropriate regulatory agencies and ISO registrars
- Continue to develop and enhance current regulatory knowledge at both the local and national levels to support surveillance activities
- Lead the support of currently marketed products including review of engineering changes, labeling, promotional material, product chances and documentation of changes requiring government approval
- Responsible for proposing and execution of Quality System improvement opportunities, and developing and maintaining Business Continuity Planning programs
- Responsible for writing, reviewing and approving validations in accordance with customer and regulatory requirements
Qualifications for quality & compliance manager
- Advanced knowledge and technical proficiency with Microsoft Office applications to include Word, Excel, and PowerPoint
- At least five years of quality and compliance experience, preferably with consumer products and product certification and/or five years of experience working with supplier quality management
- A bachelor's degree in engineering or equivalent work experience
- Native fluency in Chinese and advanced fluency in English
- Pharmaceutical legislation and regulations (CFR, ICH, Ph
- You have strong communication and negotiations skills and you are characterized by a strong analytical, self-organized and highly flexible personality