Sr. QA Compliance Specialist
Fulltime- Direct Hire- On-Site
Reports to: Sr. Director, Quality & Compliance
Job Summary:Responsible for the overall regulatory and internal audit programming including audit execution, reporting, and follow-up of internal GMP operations. As such, responsibilities include conducting audits to ensure adequate application of GMP quality principals; GMP audit reporting; GMP audit corrective action recommendations and verification; and notification of discovered significant GMP deficiencies and subsequent corrective action updates to Senior Quality Management, Commercial Operations, Regulatory Affairs, and Supply Chain groups. Responsible for ensuring compliance with US Drug Enforcement Agency and Florida Department of Business and Professional regulations.
Responsible for the overall quality and qualification of materials and products supplied for distribution and/or further processing. As such, responsibilities include supplier / material qualification; material, intermediate, and product specification quality reviews; establishment and adequacy of Quality Agreements between the company and Vendor / Supplier / Contractor; and coordination of associated testing, audits, and compliance verification.
The function is to identify through the examination and written evaluation that quality systems have been implemented, maintained and remain effective for the various processes/departments.
- Perform internal audits of all areas identified in the internal audit schedule, and ad-hoc/for-cause audits as required, to assess compliance with site policies/procedures, regulations and Global Policies and Procedures.
- Document audit observations in a detailed written report and provide compliance assessment for the area/system/process audited. Perform a risk classification of all observations and communicate any critical or major observations to senior management.
- Conduct follow-up meetings with departments to ensure that internal audit observations are being addressed and that the agreed corrective and preventative actions are completed on time.
- Maintenance of audit data and files for internal audits performed.
- Oversee DEA compliance and reporting activities including maintaining registrations, security of controlled drug storage areas, inventory reporting, permits and quotas.
- Oversee compliance with Florida Department of Business and Professional regulations including pedigree requirements, registration and licensing.
- Provide support for Regulatory, Client, Internal and Corporate Audits
- Develop and implement appropriate business processes and controls including SOPs, in order to maintain effective quality standards
- Develop metrics and manage communication and tracking system to assure CAPA closure
- Manage personnel in group, including hiring/ disposition of personnel, conducting performance reviews and providing support for the development and management of relevant staff training/ development
- Support business development process through due diligence and partner audits
- Develop and maintain effective relationships with internal business unit and sites
- Review and approval of audit trend reports
- Manage the Supplier Qualification Program to ensure raw materials, intermediates, and products supplied to the company are of suitable quality for manufacturing processing and/or commercial distribution
- Manage the supplier status review process to evaluate suitability of vendor and suppliers
- Manage the supplier qualification
- Relationship with Internal/External Customers & Stakeholders
- Develop and maintain effective relationships with Clients, Affiliates as well as Operation Directors, and Supply Chain Group in order to ensure timely audits, communication, and resolutions to discovered GMP deficiencies and/or concerns
- Identifies root cause to complex and/or broader problems-develops solutions and implements action plans to mitigate risks, informing and escalating as required
- Responsible for the operation of GMP Auditing including project planning and resource management
- Make decisions and provides recommendations to senior management that have direct impact on quality and subsequent commercial manufacturing operations and/or product supply product
- Evaluation of SME audit responses to ensure each observation has been adequately approved
- Works with the Senior Management to ensure the continuous development and improvement of GMP Auditing operations
- Set department priorities/goals/metrics and assists direct reports in priority setting
- Performs all work in accordance with all established regulatory and compliances and safety requirements
- Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance
- Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to:
- Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our global job description processes.
- Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Global Training and Employee Qualification Enterprise Policy.
- Effectively managing performance for direct reports according to the Global Performance Management Program,
- Attracting and retaining talent based on our talent management framework.
- Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions.
- Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
- Responsible to ensure compliance of team members (direct reports) with the Global Business Ethics and Compliance Program, Global Quality procedures, Safety and Environment policies, and HR policies.
- Works as a member of a team to achieve all outcomes
- Leads with a global mindset that respects all cultural dimensions
- Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
- Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and
- All other duties as assigned.
- Minimum 8 years of experience in the GMP Regulated industry, 2 years of which has been spent in the Quality Control Unit
- Experience using TrackWise(QMS) software platform a plus!
- Experience in audit needed
- BS. in Chemistry, Biochemistry or a related science
- Thorough knowledge of GXP requirements
- Clear and concise written and verbal English communication
- Strong communication, interpersonal and organizational skills
- Knowledge of excel, word, other Microsoft office programs
Competitive Salary, bonus, benefits, Generous PTO, and more!
Please send your updated resume in a word document
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