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Manager, quality management, corporate compliance skills for your resume and career

15 manager, quality management, corporate compliance skills for your resume and career
1. Management System
A management system is a set of policies, processes, and procedures taken by an organization or a business to ensure it can fulfill its tasks and achieve its objectives. A management system makes sure that the company excels financially and improves the user experience. The management system also takes care of the worker's and employees' needs and manages their workload and oversees their performance. Apart from interior matters of the company, a management system also deals with exterior matters like legislations, tax matters, and law issues.
- Developed, maintained and implemented Quality Management System standards, procedures and instructions in conjunction with Departmental Managers.
- Prepared training manuals and assisted in writing standard operating procedures for case management system.
2. Continuous Improvement
Continuous improvement is an ongoing process of improvement of products, services, and processes with the help of innovative ideas. It is an organized approach that helps an organization to find its weaknesses and improve them.
- Develop and facilitate cross-functional and continuous improvement teams, administering company's personnel policies and oversee department budget.
- Identify continuous improvement areas through customer feedback and non-conformance trending.
3. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Reviewed, authored and executed the remediation plans, updated validation and qualification documentation for the up coming FDA remediation visit.
- Project consists of creation of curriculum for certification of competency/mastery FDA Compliance Validation management for presentation at Stanford.
4. CAPA
- Investigated quality issues, verified root cause, initiated and tracked CAPA through to effective closure.
- Worked with multi-functional teams to complete CAPA.
5. Quality Compliance
- Provided trending and reporting information to monitor quality compliance.
- Managed a team of 26 quality compliance auditors who perform post-delivery quality audits to ensure contract compliance.
6. Quality System
A quality system is an organizational structure that helps management, procedures, and processes. The quality system helps the company to achieve its goals by following the right procedures. The quality system is usually documented and is based around a manual that defines and controls the system.
- Report to upper Management on overall Quality Systems and improvements initiative.
- Increased awareness of quality system requirements.
7. Audit Findings
- Report audit findings in writing to Management of audited site and to Pfizer Management.
- Reduced audit findings by 50% including no major findings on last audit.
8. Regulatory Compliance
- Lead management during targeted regulatory compliance examinations
- Maintain Regulatory Compliance Budget Supervise and coordinate activities of all Regulatory Compliance Staff Chair and direct the GNYHCFA Interdisciplinary Coalition Group.
9. ISO
- Ensured the BSC complied with all internal and external requirements through the following: o Maintaining ISO 9001 certification.
- Upgraded compliance levels for design and engineering including ISO 10993, IEC 60601, and ISO 14971.
10. HIPAA
- Revised company's HIPAA policy and developed implementation plans to comply with U.S. HHS requirements.
- Supported HIPAA polices by implementing and managing the document retention polices for the operations group.
11. Governance
Governance is the means by which countries or organizations are overseen or controlled by their leaders. This may be through laws, regulations, policies and processes that guide behaviour in a way that upholds the principles defined by the leaders. Often, they come with consequences for breach and reward for implementation.
- Researched, evaluated and implemented Governance Risk Compliance (GRC) Software.
- Chaired Service Desk Governance Board with key business unit leaders.
12. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Managed GMP auditing of primary, 3rd party manufacturers and supplier risk assessment.
- Facilitate concurrence presentations, issue resolution and decision making with appropriate senior management GSP and GMP governance councils.
13. Sops
A standard operating procedure or simply SOP is a particular operation that needs to be done in accordance with the rules and guidelines of a company or an industry. It is an important way for a company to run smoothly, especially in small businesses. It is like a practice wherein everything an individual or an employee is under a particular standard that is implemented.
- Review SOPs and perform SOPs training Keep department updated with current version of USP and European Pharmacopeia
- Developed SOPs, annual reports, and GCP related policies and procedures, and trained research and other staff.
14. Compliance Program
A Compliance Program is a collection of rules, policies, and processes which are found within a company, business, organization, or some other form of an institution, all of which are created and followed with the main purpose of compliance with the laws, rules, and regulations of a country or of an industry, or to otherwise uphold some idea or reputation and quality of a company and its work. It is also known as the compliance and ethics program of a company.
- Established company s fleet safety compliance program, including records management, training, insurance, registration, maintenance and claims.
- Developed and ran the compliance program including creation of the compliance manual and employee handbook.
15. GxP
- Managed GxP inspections by domestic and international regulatory agencies.
- Managed, along with budgetary responsibility, for a direct staff of 16 GxP Quality Managers within Europe and North America.
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List of manager, quality management, corporate compliance skills to add to your resume
The most important skills for a manager, quality management, corporate compliance resume and required skills for a manager, quality management, corporate compliance to have include:
- Management System
- Continuous Improvement
- FDA
- CAPA
- Quality Compliance
- Quality System
- Audit Findings
- Regulatory Compliance
- ISO
- HIPAA
- Governance
- GMP
- Sops
- Compliance Program
- GxP
- CMS
- QMS
- Compliance Issues
- Medicare
- Lean Six Sigma
- Medicaid
- Corporate Risk
- GRC
- Cash Management
- Health Plan
- Contract Compliance
- Trend Analysis
- Compliance Training
- HEDIS
- Direct Reports
- Peer Review
Updated January 8, 2025