Manager, Compliance

Manager, Compliance

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Site Quality Director

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

フルオンサイト

あなたがすること

The Manager, Compliance is responsible for continuous improvement of site cGMP compliance. Responsible for assuring competitive compliance with current GMP enforcement, while aligning strategically with company quality/compliance initiatives. Provides compliance consulting to the process, ensuring that Plant operations consistently meet the requirements of cGMP's. Ensures that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards. Engages upper Plant Management to appropriately prioritize and put compliance improvements in place. Manages staff to prepare for, coordinate and host regulatory and corporate audits as well as manage audit responses and follow-ups. Management of the complaint system and support to the company complaint process. Provides compliance training opportunities for the Plant, interfaces with Regulatory Affairs and Home Office Compliance as needed, and manages the Site Quality Management Review Process including monitoring and interpretation of metrics and compliance risks. May be responsible for review and approval of investigations, change controls, notifications to management and other quality system documentation as needed.

Key Responsibilities:

Ensure quality and compliance in all my actions by:

• All employees
  • Attend GMP training on the schedule designated for my role and as appropriate for my role.
  • Adhere to strict compliance with procedures applicable to my role.
  • Exercise the highest level of integrity in the tasks that I perform.
  • In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
  • Embrace a behavior of employee involvement and commitment to doing the job right the first time.
• People Managers
  • Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
  • Promote an environment of employee involvement in the workplace.
  • Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.
     

Compliance Focus:

• Provide compliance consulting to the process, ensuring that site operations consistently meet the requirements of cGMP’s. Ensure that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards.
• Manages site forums for continuous improvement –coordination/facilitation of meetings.
• Engagement of upper Management to appropriately prioritize and put compliance improvements in place.
• Preparation, coordination and hosting of regulatory and corporate audits for the site. Coordinate audit responses and follow-ups.
• Provision of compliance training opportunities for the site as needed.
• Manages the site quality management review program including monitoring and interpretation of metrics and compliance risks.
• Manages the site’s Internal Auditing program.
• Oversee the site’s Complaints program and complaint investigations.
• Oversee the site’s Supplier Quality process.
• Escalates issues as required to Home Office compliance and tracks follow ups/resolution.
• Oversee the site’s Retention sample program.
• Responsible for managing the site’s Inspection Readiness Program, including regulatory agency preparedness and pre-approval inspection readiness.
• Ensures coordination with other NA Kenvue Make sites and publication of the annual schedule of internal audits.
• Participates and provides support for the Global Notification to Management process.
• Develops and manages the Compliance budget.
   

People and Organization Focus:

• Provide direction and mentoring to supervisory and lower-level quality professionals in meeting their tactical and strategic initiatives – focusing upon the support of ongoing base business, new product/process introductions and system improvements – in a compliant, cost-competitive manner. Ensure that performance appraisals are routinely conducted, with development and succession plans in place.
• Provide compliance support in project meetings as needed.
   

Sharing Knowledge:

• Mentor site leadership on cGMP interpretation, application and current enforcement. Promote partnerships with company sites and Compliance teams.

Required Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Natural Science or equivalent combination of experience
• Minimum of 8-10 years of professional experience with at least 2 years of supervisory experience
• Demonstrated experience with key leadership and decision-making positions
• The ability to determine the need for process interruption
• Strong organizational skills/facilitation skills
• Fluent knowledge of cGMP regulations and guidelines, as well as the ability to interpret requirements
• Demonstrated experience managing and/or supporting Board of Health inspections including Prior-Approval inspections
• Strong verbal, written and presentation skills
• Strong skills in partnering and influencing
• Excellent communication and leadership skills

Desired Qualifications

• Knowledge of regulations and requirements for procuring, storing, manufacturing, and handling listed chemicals and controlled substances
• Previous experience interpreting the regulations and laws governing the procurement, storage, manufacture and handling of listed chemicals and controlled substances
• Experience in preparing for inspections by the US Drug Enforcement Agency
• Experience in hosting and managing inspections by the US Drug Enforcement Agency

それは何ですか

$124,100.00 - $175,200.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

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