Director Product Quality Integrator

Abiomed

10 - 15 years

20 - 25 Lacs

mumbai

Posted:19 hours ago| Platform:

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Skills Required

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Ensures product quality for patients.
Represents Global Quality on the CMC and Value Chain (VCT) Teams. Provides liaison between VCT and Analytical group. Serves as the single point of Global Quality contact for an assigned group of products. Establishes and develops strong working relationships with business partners (within SC, TDS, and J&J) on a global basis. Drives communication within Q&C.
Represents Product Quality Management (PQM) in a leadership role in various multidisciplinary project teams, committees and special projects as assigned. Provides oversight for the development and maintenance of specific programs and/or projects.
Ensures Quality milestones and Quality stage gate deliverables are achieved. Quality reviewer/approver of health authority submissions (i.e., BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Supports PAI audits for the product assigned.
Has line management responsibilities, leading a group of Senior Managers or Managers. Is responsible for one or more products directly and for other products through the team.
Mentors within Product Quality and Quality Integrator sub-team.
Defines and coordinates the necessary Quality resources.
Assures product quality development through launch, understands the performance, and risk profile.
Supports the manufacturing sites, represents the sites on CMC and VC teams.
Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Participates in Product Strategy Reviews, in alignment with the Supply Chain Product Strategy with other existing strategies (J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.).
Ensures that Global Quality processes are followed, maintained and communicated, during development and across sites (e.g. PPQS, criticality analysis, complaints).
Remains current in knowledge, skills and industry trends. Trains on new regulations, guidelines, procedures and processes. Makes a positive contribution by making suggestions for improvement.
Demonstrate high knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
Gives inputs and provides guidance on production quality and packaging application related subjects.
Presents project updates to Quality leadership for Global Q&C alignment in advance of Stage Gates and commercial sourcing decisions.
Escalates issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, participates and/or leads Issue Management teams. Supports field actions / recalls as needed.

Decision making and Problem Solving:

Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
Identifies and provides balanced management of quality and compliance risks with business needs.
Collaborates and supports the organization on transformation initiatives.
Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of high risk, uncertainty and ambiguity.
Is expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs, thus providing the best total value to the company.

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