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.