Halo Pharmaceuticals

  • Manager, QA Compliance

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    The Quality Assurance Compliance Manager is primarily responsible for promoting compliance and a continuous improvement culture to drive process and cost improvement. This position will interact with departments within Halo to critically evaluate quality systems in order to support process improvements. Plan, organize, implement and support team centered continuous improvement activities.  Responsible for the identification & resolution of non-value added activities, development of cost reduction projects utilizing root cause corrective action and process maps for effective problem solving.

     

    Responsibilities

    • Evaluate quality system processes recommend improvements in compliance with regulatory requirements.
    • Engage and align with other diverse and dispersed organizations and functions, building teamwork.
    • Partners with others and leads and motivates an organization in driving continuous improvement and change, improving customer satisfaction.
    • Provide support during regulatory inspections and client audits as applicable
    • Provides inspection readiness support to the site -identification of compliance gaps and risks, and participation in the remediation process.
    • Participate in inspection preparation, and participate in regulatory inspections, defending Deviation/CAPA policies and practices.
    • Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.
    • Develop Deviation/CAPA policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems related to Deviation/CAPAs. 
    • Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
    • Manage product complaints for commercial and clinical investigational products.
    • Interaction with customers through management during complaint process and audits.
    • Identify gaps in complaint handling /deviation /CAPA process as it relates to reporting, metric, and trending to maintain seamless compliance and develop feasible plans for correction.
    • Author Annual Product Reviews
    • Possesses regulatory and business knowledge to champion improvements to the quality systems.
    • Integrate risk management with current and emerging processes.
    • Author and/or review and implement SOPs to ensure compliance with current Halo standards and cGMP
    • Other duties as assigned.


    Qualifications

    • Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements. Of particular importance understands quality systems. Possesses some knowledge of project management tools and has some experience leading cross functional teams. 
    • Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
    • Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
    • Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Ability to prioritize and respond to changing business demands.
    • Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices. Strong problem solving skills and analytical assessment for continuous improvement.
    • Able to critically think, assess problems and collaborate to come to an appropriate resolution. Proactive and driver of continuous improvement operations. Applies risk management philosophy to business processes, decisions, and data
    • Innovation- Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Applies risk management philosophy to business processes, decisions, and data
    • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    EDUCATION:  

    • Bachelor's degree (B.S.) from four-year college or university in engineering or sciences preferred.

     

    EXPERIENCE:

    • 5+years related experience and/or training; Supervisory experience.  Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable.

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