Associate Director Corporate Quality Compliance - United States
- Plans and develops corporate quality audit and compliance programs that span all applicable GxP and PDMA regulations (i.e. GCP, GLP, GMP, GPvP in the Food, Medical Device and Pharmaceutical sectors) to gage compliance status of our company sites, external operational sites, suppliers and service providers.
- Monitors global regulatory landscape and disseminates emerging trends and/or observations that may affect our company’s corporate and site compliance risk management programs worldwide.
- Corporate Quality Compliance introduces Quality Compliance practices and programs with the objective of maintaining and improving the Company’s compliance profile & performance.
- Continually improves company’s Corporate Quality Audit and Governance Programs to ensure robust processes and systems which effectively assess the compliance risk profile of company sites, suppliers, service providers and potential merger and acquisition targets.
- This includes accountability for company’s Corporate Quality Governance and Internal Audit Programs. Includes matrix responsibility for GCP and Supplier Audit Programs.
- Accountable for comprehensive audit programs that evaluate GxP within the organization and with global vendors and service providers.
- Works with company Sites and functions to ensure that inspections and audits are conducted on continuing basis as required by applicable legal requirements, regulations and company Policies and Standards. Participate/ Lead Corporate Quality internal audits.
- Certifies completion of audits and oversees the implementation of corrective actions.
- Accountable for Corporate Quality Governance Programs including Escalated Quality Events / Global Quality Review, company global regulatory inspections, regulatory authority landscape, and company’s Data Integrity Program.
- Matrix responsibility for supply chain quality compliance and security issues.
- Accountable for detecting, analyzing and communicating emerging Quality Compliance trends to company global sites, company Quality leadership and the Executive Committee. Accountable for Prescription Drug Marketing Act (PDMA) Compliance Program to ensure full PDMA compliance through appropriate training and monitoring of Rx Specialty Sales force with regard to Sampling programs to Health Care Practitioners.
- Ensures timely reporting of all FDA-reportable events and the annual Affordable Care Act report.
- System owner for Corporate Quality data systems including TrackWise Audit Information Manager and data systems that capture Corporate Quality Governance data, including escalated quality events and global regulatory authority GxP inspections.
- Develops and manages the sourcing, vetting and monitoring of the use of outside consulting resources to support corporate audit and governance programs.
- Global Accountability for company GxP Training programs in collaboration with HR training. Defines minimum standards for GxP Training for all company Sites and Functions. Establishes and works through Global Network to assess, standardize and improve GxP training across the company.
- Bachelor’s degree in a scientific or technical discipline combined with considerable progressively responsible professional and managerial experience in the pharmaceutical and consumer health care industries.
- Seasoned professional with a minimum of 15 years of experience in Quality Compliance in the pharmaceutical, medical device and/or food industries.
- Must possess expert knowledge of cGxP and have experience conducting cGxP audits and initiating and implementing Quality Compliance Programs.
- Understanding of global GxP framework in company’s major markets, at a minimum including US and Europe.
- Strong leadership skills are preferred.
- Excellent oral and written communication skills are required, as are strong interpersonal skills, in particular the ability to influence across all levels of the organization.
- Excellent planning skills are also necessary.
- Strong analytical skills are required.