General Manager - Quality - Pharma

JOB SUMMARY

Leads Quality Team and supervises overall execution to quality processes at India plant, including production quality for blood bag (BBF), medical equipment (MSG), and QMS complaint activities across. The Sr. Mgr, Quality Assurance ensures the ability to produce a high quality product, processes are aligned with regulations and standards, and aligned efficiently and compliantly with BCT policies and procedures, and owning the ongoing continuous improvement, maintenance, execution, of QMS area(s) of responsibility. This role is responsible for product quality support through all phases of production and participates fully as a member of the leadership team to ensure we meet customer expectations of the highest quality product conforming to all required regulations. This position reports a senior Quality leader, and interacts regularly with other Quality functions, as well as other functions within the facility.

ESSENTIAL DUTIES -

- Operations Quality areas of ownership, management, and responsibility may include (as assigned): Incoming product testing, QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non conformance investigation and controls, Product Release, Supplier management, CAPA, Audit (internal, external, supplier), Quality System Training, Document Control, Management Review, etc.

- Oversee Quality Engineering, Calibration department, Receiving Quality Assurance (RQA) through final Quality Control and release, with other Operations Quality functions as required.

- Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.

- Identify and drive improvement projects to either gain efficiency, improve product quality or cost down.

- Oversee and manage non-conformance (NC) process and root cause investigation. Work with cross functional team to drive improvements to systemically eliminate repeat NCs or other forms of variation or defect.

- Oversee the throughput and backlog of inventory in incoming and final inspections.

- Oversee calibration and maintenance of all equipment and tooling in the site, facilities, custom tooling at applicable suppliers, and custom service equipment worldwide.

- Partner with other functions or quality departments to monitor and manage quality across both design transfer or supply chain to ensure high quality production for either new product development or older products.

- Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.

- Owns and executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations to ensure efficiency and compliance. This likely includes: generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.

- Serves as Point of Contact, Subject Matter Expert and process owner for their QMS area(s) of responsibility during audits and inspections.

- Monitors the product quality and compliance health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.

- Identifies and implements continuous improvement opportunities within their area(s) of responsibility.

- Manages and provides operational leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.

- Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.

- During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.

The above statements are intended to describe the general nature of level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of associates so classified. All associates may be required to perform duties outside of their normal responsibilities.

Job Description

- Interfaces with QMS area owners and project teams from other BCT locations, regions, and corporate.

- Provide inputs to validation strategy and on-time completion of validation activities to meet project plans

MINIMUM QUALIFICATION REQUIREMENTS

Education

- Bachelor's degree in Engineering or a Scientific field and experience sufficient to successfully perform the essential functions of the job may be considered.

- AQL Certification, formal LEAN manufacturing training and/or Six Sigma desired.

Experience

- Minimum 10 years experience.

- Preferred minimum 7 years experience in Quality Assurance with a heavy emphasis on factory operations, QC testing, product release and nonconformance management. Some experience in a multinational company, preferred.

- Minimum 5 years supervisory experience.

- Preferred training in applicable regulations and standards of Quality Systems and ISO 13485.

- Demonstrated ability to improve product and process quality through the use of quality management techniques, such as LEAN Six Sigma, First Time Quality (FTQ) initiatives; Experienced in high volume automated assembly of medical devices.

- Experienced in leading audit responses to various notified bodies.

- Prior experience in manufacturing/operations quality role leading and overseeing group of engineers and scientists

- Excellent leadership skills, ability to identify and hire talent to support the business needs

- Good communication and presentation skills, especially with higher management on business-critical initiatives

Skills

- Knowledge of U.S. and international medical device regulations and standards (including CFR 820, MDD and ISO 13485)