Compliance Program Manager Job Description

Compliance Program Manager Job Description Template

Our company is looking for a Compliance Program Manager to join our team.

Responsibilities:

  • Effectively communicates with teammates and key partners;
  • Conducts other related activities and duties as assigned, including support core compliance program elements;
  • Build a compliance program and drive strategy for software, instruments, reagents, and service offerings for our regulated customers;
  • Ensures appropriate oversight of confidential compliance hotline and escalated issues;
  • Deliver training and support to global sales team and other business units within Molecular Devices;
  • Provide support for corporate compliance functions specific to organizational vulnerability/risk assessment and gaps;
  • Managing changes to project scope and schedule;
  • Supports the development, assessment, measurement and reporting of ongoing compliance initiatives;
  • Assists in Corporate Compliance Committee activity and assessing overall compliance program effectiveness;
  • Support pharmaceutical and regulated customer key accounts and participate in customer audits;
  • Works closely with compliance committees/compliance liaisons to develop, implement and manage compliance activities;
  • Monitors the performance of the compliance program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness;
  • Ensuring work is delivered on time and within budget;
  • Attends and participates in the Audit Compliance Meeting, Risk Adjustment Committee meeting and other compliance conferences/meetings as required;
  • Assists with compliance auditing and monitoring activities.

Requirements:

  • 10 years of experience in program management;
  • Master’s, PhD degree, further education or equivalent experience in Engineering, or other technical related field;
  • Influential member of a highly integrated team composed of both technical and non-technical members;
  • Excellent attention to detail, high standards adopted at all times;
  • GMP/GLP certification a plus;
  • Minimum of 5 years’ relevant GMP/GLP experience in quality systems in the pharmaceuticals industry;
  • Detail oriented and demonstrated ability to perform work with high degree of accuracy;
  • Conducts other related activities and duties as assigned, including support core compliance program elements;
  • Effectively communicates with teammates and key partners;
  • Strong organizational and planning skills. Must work effectively within teams;
  • Stretch oriented. Embraces and thrives on challenge;
  • Strong knowledge of computer system validation, GAMP, data integrity and compliance to FDA 21 CFR Part 11;
  • Experience in GMP/GLP auditing;
  • Works closely with compliance committees/compliance liaisons to develop, implement and manage compliance activities;
  • Monitors the performance of the compliance program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness.