Quality Assurance Manager

Shift Hours: Monday- Friday 8:00AM- 5:00PM

Please note, flexibility in schedule will be required based on business needs, this can include working different hours or days.

Location: This position is located onsite at our facility in Hawthorne, CA. There is no option for remote or hybrid work. 

This role is in support of Cencora's global logistics and storage services marketed through our World Courier business.

This role, as a quality representative plays a crucial role in ensuring compliance with World Courier policies and procedures at the local level. They are responsible for overseeing quality-related activities within the Transport divisions of the organization. They provide guidance to office and divisional associates on matters of quality and compliance. Additionally, they are responsible for ensuring compliance with local regulatory requirements related to operations and may have regulatory responsibilities in front of local authorities.

Duties and Responsibilities:

• Quality Management System (QMS)QMS Management: Developing and maintaining a robust QMS that defines the organization's quality objectives, policies, procedures, and performance metrics. This includes acting as a first contact for the Country Manager and local team for quality related topics. And to ensure that quality aspects for CCS and Transport are adequately represented during local and global meetings as well as local and global projects and initiatives. Organize and support management review meetings in accordance to applicable SOP.
• Supplier Qualification Management: Oversee the Suppliers Evaluation Program in accordance with internal guidelines, including local suppliers approval / rejection. This involves working closely with subject matter experts and the local operational team to ensure that subcontractors and suppliers meet the necessary qualifications and standards. To ensure supplier meet quality expectations through supplier audits, performance monitoring, and corrective actions when necessary.
• Quality Agreements: To review and negotiate quality agreements and Confidentiality Disclosure Agreements (CDAs/NDAs). This includes carefully examining the terms and conditions outlined in these agreements, ensuring alignment with company policies and regulatory requirements.
• Internal / External Audits, Inspections and certification audits: To be the main auditor contact and to communicate with relevant parties within the organization. To initiate and oversee the audit organization. Respond promptly to auditor inquiries by providing accurate information, supporting documentation, or clarification as needed. Work with management teams to develop and follow up action plans for addressing any identified non-compliance issues and provide audit responses in due time.
• Incident Management: Review and manage the documentation on incidents. Actively participating in investigations on non-conformities or deviations from established quality standards. Provide quality input for investigations, root cause analysis and CAPA and support corrective and preventive action initiatives to address root causes. Assisting in the creation of comprehensive reports, and diligently monitoring deviations and subsequent actions as outlined in the specific internal guidelines. Reporting to global QA and local leadership any deviations or potential problems.
• Ensuring that relevant customer complaints are dealt with effectively.
• Risk Management and Change Control: Assist in setting up and to participate in Risk Management and Change Control processes. To ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansions, depot moving process, regulatory updates clarifications, etc.
• Pest Control and Facility Cleaning: To ensure that pest control and cleaning programs are properly implemented and documented following applicable SOPs.
• Technical Quality Support: Overview and verify technical change controls, calibration, maintenance and qualification / validation program according to internal guidelines, supporting the local facility representative and QA manager technical compliance. Support the review of temperature graphs as defined in applicable SOP.
• Documentation Management: Ensuring accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc. This also includes to organize regular reviews of, e.g. Local Standard Operating Procedures (SOPs) and Work Instructions (WIs) with the process owner / author. To support the review of these documents to ensure that they align with established service standards as well as quality and regulatory requirements.
• Quality Data Management: To execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools). This includes accurately inputting and timely updating data, attaching relevant documents, tracking progress, documenting actions taken, and adhering to any specific workflows or process as outlined in the standard operating procedures.
• Quality ControlQuality Checks and Control: Implementing processes to monitor product or service quality throughout the entire lifecycle from design to delivery. This may involve conducting inspections and analyzing data to ensure accuracy and quality of records, to identify defects or areas for improvement.
• Self Inspection and Quality Checks: Responsible for quality related activities related to the Self-Inspection Report as well as quality checks as defined in standard procedure.
• Compliance Assurance: Ensuring compliance with relevant regulations (local law, GDP, quality regulations etc), industry standards (such as ISO and relevant GxP standards), customer requirements, and internal policies. Staying up-to-date with changes in regulations and triggering / implementing necessary QMS changes.
• Verifying adherence of World Courier employees to all Company Policies and Procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation.
• Ensure that World Courier License(s) as well as any other regulatory documentation is/are properly in place and updated as applicable.

• Quality Training and Education Training Program: Developing training programs to educate employees on quality standards, quality processes, and quality techniques. Ensuring that initial and continuous training programs are implemented and maintained related to Good Documentation, Good Manufacturing, Good Distribution and Good Clinical Practices (when applicable).
• Internal Guidelines Training Management: To assign along with the local Management and maintain the local training job codes and local training matrix. To monitor training compliance and escalate non-compliance to local management.
• Process ImprovementContinous Improvement: Identifying opportunities for process improvements through data analysis and continuous evaluation of existing workflows. This may include implementing Lean Six Sigma methodologies or other improvement frameworks in collaboration with the Continuous Improvement department.
• Customer Satisfaction: Participate in client meetings, monitoring client feedback and satisfaction levels to identify areas for improvement in services. To enhance the quality of service delivered to clients by closely collaborating with the operational team.
• Others: Keeping appropriate records of any delegated duties and execute tasks and responsibilities as per delegation plan or assigned to the QA support team. Any other quality responsibilities assigned by Regional/Global Quality Management.

People Management:

• Conduct resource and talent planning: Responsible for overseeing and evaluating employee contributions, performance, and development within the operational quality team. This includes assessing skills, identifying training needs, and ensuring that the team has the necessary resources to perform duties effectively.
• Monitor work processes and organize work allocation: In charge of monitoring work processes within the team to ensure efficiency and effectiveness. This includes organizing work allocation, assigning tasks to team members based on skills and workload capacity.
• Implement regular one-to-one meetings: To provide an opportunity to discuss activities, priorities, progress, and any problems the team may be facing. Help foster open communication and ensures that everyone is aligned with goals.
• Organize or initiate regular team meetings: Responsible for organizing or initiating regular team meetings where knowledge sharing takes placein order to address common challenges or problems faced by the team collectively.

Regulatory Responsibilities

• Ensuring along with local management / that requirements imposed on certain products by national law are adhered to.

Education:

• Bachelor's degree in life sciences, business administration, supply chain, or a related field, or equivalent experience required.
• Certified in ASQ Certified Quality Auditor (CQA), Certified Professional in Healthcare Quality (CPHQ), ISO 9001 Lead Auditor (QMS), or equivalent preferred.
• Certified in Lean Six Sigma Green Belt or Black Belt certification preferred.
• Certified in ISTQB Certified Tester – Foundation Level (CTFL) preferred.

Experience:

• Five (5) + years of experience in quality assurance/quality management within a regulated and/or operational services environment (e.g., GxP/GDP, logistics/distribution, shared services, customer contact centers, or technology delivery), or a related field required.
• Two (2) + years of experience in a management capacity required.

Skills and Abilities:

• Thorough knowledge of regulatory compliance matters.
• Ability to communicate effectively both orally and in writing.
• Effective presentation skills.
• Ability to train, motivate and direct the work of others.
• Ability to plan and conduct effective meetings.
• Strong analytical and mathematical skills.
• Strong interpersonal and leadership skills.
• Strong organizational skills; attention to detail.
• Ability to meet deadlines and work in a production-driven environment.
• Strong decision making skills.
• Excellent problem solving skills; ability to resolve issues effectively and efficiently.
• Excellent skills in Microsoft Office (Excel, Word and PowerPoint).   
• Able to work independently and with a team when required.
• Must be able to travel overseas if required.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

$73,600 - 147,290

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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Affiliated Companies:

Affiliated Companies: World Courier Inc