Senior Managers Product Quality Integrator

Job Title

Senior Managers Product Quality Integrator

Johnson & Johnson Innovative Medicine is recruiting globally for 3 Senior Managers Product Quality Integrator (PQI) in the Product Quality Management Synthetics organization and reporting to the Sr Director PQ Launch&Grow.

Responsibilities

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.

Supports PAI audits for the product assigned.

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 representing 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.

Qualifications

Minimum 5 years of experience in quality, compliance or a scientific discipline in the pharmaceutical industry.

Minimum of Master / Bachelor's degree in a scientific discipline, and it is essential that the individual has excellent scientific & technical capabilities based on a combination of qualification and experience.

Demonstrate basic knowledge of financial management, budgeting, and business case calculation.

Experience And Skills

Project management experience.

Excellent communication and organization skills required.

Strong presentation, written and oral communication skills as well as the ability to meet due dates.

Attention to detail and analytical / problem-solving skills.

Business oriented, independent, and driven.

Experience in leading a global team is a plus.

Demonstrated leadership in bringing products through development to launch is a plus.

Other

Proficient in English.

Travel : approx.

10% of time based on specific business needs.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) :

Italy, Belgium, Switzerland, Ireland, India - Requisition Number : R-

United States - Requisition Number : R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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