The Senior Manager, Global Commercial QA is responsible for implementation of the QMS as well as compliance of the affiliate / distributor network, working collaboratively with International DVP/Regional directors/country managers.
PRIMARY JOB SCOPE:
- Establish, promote and oversee continuous improvement initiatives for worldwide commercial QA functions.
- Define objectives in collaboration with executive management. Develop quality goals based on the business strategies that align with other functions in the organization as well as with the corporation. Develop plans that effectively support commercial needs in conjunction withQuality Systems Regulations.
- Implement the Quality planin accordance with the quality objectives/goals and maintain the effectiveness of the quality system.
- Promote and ensure policies and procedures are in place so that Commercial activities meet applicable regulations and quality standards, minimizing the probability of quality/or compliance issues. Company-wide quality system compliance with all applicable national and international standards and regulations.
- Determine staffing and other resource requirements needed to achieve business goals and compliance requirements. Direct complex global cross-functional process improvements. Manage department budgets and day to day activities of personnel.
- Responsible for ensuring that area of responsibility have adequate training programs for adhering to all requirements, including safety requirements and business EHS goals.
- Develop and implement necessary communication strategy for the improvement and awareness of the quality issues. Monitor/report to upper management (e.g. via Management Reviews) the status of Commercial QA.
- Work in collaboration with other Abbott commercial quality leaders.
- Interface with internal/external auditors/inspectors with regard to any commercial QA activities. Provide support for audit/inspection administration.
- Oversight of a team of 4+ across multiple geographies.
- Direct reports are located in different countries and can include those at the Manager level
CORE JOB RESPONSIBILITIES:
- Global responsibilities for quality activities related to service; affiliates; warehouses; service depots; distributors and affiliate suppliers globally.
- Must effectively communicate, prepare, influence and negotiate both internally with Sr. levels/executives and externally with regulatory bodies and key partners; failure to do so will have a direct impact on market presence.
- Requires domestic and international travel
- Supports APOC business objectives and provides sound leadership for implementing measurable actions
- Assures compliance with applicable regulatory standards, ensuring the safety and efficacy of APOC’s products and successfully meeting the business needs and objectives of the division.
- Assures affiliates and distributionpartners have adequate systems in place to store and distribute APOC’s products
- Decision and recommendations made by this position have a direct impact on marketed items for domestic and international sales.
- Minimum of 8 years’ experience in Commercial Quality Assurance, Supplier Management, Regulatory Affairs and or Compliance.
- Minimum of 6 years management experience in the diagnostics (preferred), medical device or pharmaceutical industry.
- Knowledge of regulations and standards affecting IVDs or Biologics across multiple countries/geographies highly desired.
- Ability to communicate effectively and build credibility with senior business leaders and external regulatory bodies.
- Demonstrated experience and capability working successfully across multiple cultures.
- 25% International travel
- Bachelor’s Degree preferably in the life or physical sciences, Engineering,Bioengineering or other science disciplines (Biology; Chemistry; Biochemistry; Clinical Chemistry; Med Tech: etc.) or substantial equivalent experience.
- ASQ CQA or CQE highly desired