**Description:**
Position Summary
The Director of Quality \(Manufacturing\) Medical and Life Sciences Segments Greater Asia \(the DQM GA \) reports functionally to the Vice President, Quality Medical Procedural & Solutions and dotted to Vice President of Operations Greater Asia and the Director of Quality \- Greater Asia and has responsibility for leading the development and implementation of the strategic quality plan in collaboration with the respective BD Business Unit Quality teams across the Medical and Life Sciences Segments for Greater Asia\. The DQM GA will effectively collaborate and consult with all BD Business Units to assure that the strategic quality plans are implemented within Greater Asia and will adequately supports compliance activities and priorities of BD Holdings Pte\., \[as well as current Quality Management strategic themes\]\.
The DQM GA, in the context of the strategic quality plan, will strongly champion the enabling of continuous process and product improvement using the competencies being established in BD through Six Sigma and Lean Programs to support the performance and quality needs of the Greater Asian region for BD Medical and BD Life Sciences Segments BU products manufactured or sold in Greater Asia\.
In general, the DQM GA is responsible for assuring that the organizational structures, responsibilities, procedures, processes, and resources for all of the Greater Asian manufacturing sites and design centers are adequate to meet the needs and objectives of the Business Units and to conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies\.
The DQM GA will have responsibility for oversight of the Quality function for all the manufacturing facilities and design centers in Greater Asia \(e\.g\., Tuas \(MPS\) Singapore, Suzhou 1,2,3 China, Bawal India, Penang Malaysia, Tuas \(BDB\) Singapore, Fukushima Japan and Singapore \(MPS and GA\) Design Centers\) and sterility assurance activities in Greater Asia\.
Plant and Unit Quality Leaders within the sites will report to the DQM GA and are under the functional authority and functional mentorship of the DQM GA\. This includes authority/responsibility for performance ratings, career growth potential, salary and other compensation recommendations, termination and recruitment/hiring of a Plant Quality Leader\. The role of the DQM GA also is to assure that there is an effective quality resource/partner to plant operations who is able to carry out responsibilities and make decisions with independence; but such quality resource/partner still remains subject to oversight and governance by the DQM GA\.\]
II\. Key Responsibilities
1\. Responsible for leading and/or facilitating the Greater Asia Quality teams for all of the Business Units in the development of a strategic quality plan which defines the quality practices, resources, and activities relevant to products that are manufactured in Greater Asia\. The quality plan shall also establish how the requirements for quality will be met, with strong attention to developing and maintaining high performing underlying processes\. The quality plan must also include provisions for future products and any planned acquisitions\. Responsibility includes assuring that the quality plan is updated as needed, to reflect any changed business/customer needs or regulatory requirements and, that appropriate procedures are in place for the review and approval of such changes to the quality plan\.
2\. Responsible for the development and continuous improvement of the Greater Asia Quality Management function and associates to the highest professional and performance standards\. This includes appropriate training and accreditation to ASQ, QP and other relevant professional standards, certification to Six Sigma competencies \(i\.e\., Blackbelt/Greenbelt\) sponsored by BD Corporate QM and participation in leadership and skill development training offered by BDU\.
3\. The DQM GA must instill a Process Management competency and discipline in the QM function, such that it can effectively align with and support the BD Enterprise Systems, Processes and Goals, e\.g\., SAP, Documentation Systems, Supplier QM and Lean Production\. As such, the DQM GA must effectively communicate and collaborate with BD Process Owners for Integrated Supply Chain and to support their strategies and goals and to effectively represent the Quality Management interests and needs of all Business Units and their customers\.
4\. Responsible for managing and facilitating the Management Review Process, i\.e\., that Management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures and, that any improvements or changes in the quality system are implemented and documented\.
5\. Responsible for assuring that all Quality Management function associates reporting directly or indirectly from the manufacturing facilities and design centers are trained to adequately perform their assigned quality responsibilities\. Such training shall include, as appropriate, regulatory compliance related aspects of their job, such as in\-plant handling of representatives from the FDA, registrars, notified bodies and other government or independent agencies\.
6\. Responsible for relevant quality aspects of the Supplier Management Program\.
7\. Responsible for harmonizing the key initiatives within the WW Quality organization for the Business Units with a consistent approach\.
8\. Responsible for remediating significant issues relating to quality performance in connection with manufacturing at the GA sites and designs owned by the GA centers, for BD Medical and BD Life Sciences Segments\.
9\. Responsible for hosting and providing support for government and other regulatory agency audits and inspections\.
10\. Other or more specific responsibilities include:
a\. Member of the Quality Leadership Team of the Business Unit to whom he/she reports directly; and is an active participant \(or can delegate to someone within Singapore\) of the QMRs of each of the other BD Medical and BD Life Sciences Segments BUs\.
b\. Responsible through a Regional Manager of Sterilization \(and corporate resources\) for the development and implementation of procedures and controls related to product sterilization assurance, including approval of facilities used to process components, packaging and products\.
c\. Support of investigations/testing related to product complaints or internal failures, field actions, implementation of process improvements \(e\.g\., Six Sigma\) and process validation requirements\.
d\. Responsible for relevant respective pieces of the Quality Management budget development and administration, including input/review for manufacturing facility budgets, to assure adequate resourcing for Quality System responsibilities and quality function support of the business quality plan\.
e\. Support, in collaboration with other responsible management and functions, of the BD Corrective/Preventive Action \(CAPA\) process and, direct responsibility for prioritizing and implementing corrective and preventive actions relevant to the effectiveness of the business Quality System to meet regulatory and business requirements\.
f\. Accountable for respective pieces of the monthly regional plant Quality review meetings
a\. Oversee the quality system of multiple manufacturing sites and design centers across the Greater Asian region, and participate in the management of the global quality function as it is applied to the manufacture and Greater Asian distribution of all BD products\.
b\. Act as the interface for the quality function with manufacturing, R&D and marketing\.
g\. Assure adequate audits \(frequency, scheduling, scope, depth, competency of auditors, effective corrective actions, etc\.\) of Greater Asian plant facilities \(e\.g\., in China, India, Singapore, Malaysia and Japan\)\.
h\. Actively investigate and examine quality measures, i\.e\., metrics, regarding current production\.
a\. Review the quality performance \(as it relates to quality manufacturing\) of the supplying products from the Greater Asian plants to global markets \(as rolled up through Business Unit, Segment and corporate management reviews\)\.
i\. Monitor the investigation of the complaints relating to the products manufactured in the Greater Asian plants and actively monitor the implementation of necessary corrective actions\.
j\. Review and monitor corrective action\(s\) related to any complaint\(s\) arising from the sale of BD Medical and BD Life Sciences Segments BU products sold in the Greater Asia region sourced from outside Greater Asia\.
k\. Manage and oversee the Quality Management teams in the Greater Asian plants and Design Centers\.
l\. Assure adequate audits of raw material and finished goods vendors and associated remediation activities\.
m\. Assure all products produced in Greater Asian manufacturing plants comply with all internal and external quality control standards\.
n\. Monitor compliance with key quality indicators in the Greater Asian plants\.
o\. Ensure best practice and sharing of quality and regulatory information by provision of regular Greater Asia QA manager meetings\.
**Qualifications**
Education
Basic Science Degree/ Master s Degree or higher preferred\. MBA desirable\. Certified Black Belt in Manufacturing or Transactional Six Sigma or equivalent in ASQ Certification & Experience\.
IV\. Experiences
Minimum of 10 years experience in Quality Management at the Manager or Director level in the medical device/healthcare industry and, at least ten years Quality Management or Process Improvement experience in other manufacturing and/or service industries, which are recognized for supply chain excellence and customer focus\.
VI\. Required Knowledge and Skills
Knowledge and application of \[ISO 9001, ISO 13485, 21 CFR 820 and 21 CFR 210\-211, MDD & IVDD\] requirements and \[Greater Asian\] GMPs related to medical device and pharmaceutical manufacture\.
Experienced in project management\.
Organizational / motivational skills\.
Capable of managing a range of projects and activities in parallel\.
The ability to manage by influence in addition to functional responsibility\.
The preparation, planning and presentation of key initiatives\.
The ability to coordinate effectively across the Greater Asia region\.
**Job:** _Quality Management_
**Location:** _Singapore_
**Requisition ID:** _QUA102SE_