Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics

Johnson & Johnson; Horsham; On-site; USD 120,000 - 207,000; Full time

Job summary

An established industry player is seeking a Senior Manager, Product Quality Integrator, to lead quality strategies for biotherapeutics. This pivotal role involves overseeing quality aspects from development through commercialization, ensuring compliance with regulatory standards, and driving decision-making processes. You will collaborate across teams to maintain high-quality standards, manage product quality issues, and support audits. Join a forward-thinking organization dedicated to transforming healthcare and making a lasting impact on patients' lives.

Benefits

medical insurance

dental insurance

vision insurance

401(k) retirement plan

vacation time

sick leave

annual performance bonus

short- and long-term disability insurance

Qualifications

• 8+ years in pharmaceutical or biotechnology industry with strong knowledge of cGMP.
• Demonstrated ability to work across organizational boundaries and influence decisions.

Responsibilities

• Ensure Quality stage gate deliverables are achieved and serve as liaison for Global Quality.
• Lead Quality new product integration team to assure quality throughout development.

Skills

cGMP standards

risk assessment

negotiation

quality processes/systems

technology transfer

Education

Bachelor's degree in Pharmacy, Biology, Biochemistry, Biotechnology, or Engineering

Master's degree or other advanced degree

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics, to be located in Horsham, PA; Malvern, PA; Spring House, PA; Raritan, NJ; or Titusville, NJ.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine.

Purpose: The Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecules (biological) products.

You will be responsible for:

• Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned.
• Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
• Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
• Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:
  • Ensures product quality development through Launch and Grow stage.
  • Supports the sites, represents the sites on CMC and VC teams.
  • Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
  • Ensures patients get the right quality products
• Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
  • Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
  • Supports preparation of the criticality analysis per schedule.
  • Ensures complaints are well managed, issues are understood, and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics. Coordinates and/or owner of complaints trend signal investigations.
  • Partners with Product Quality Owner (PQO) Value Optimize & Late Stage to complete Transfer of Ownership activities.
• Represents Global Quality on the Value Chain Teams (VCT).
  • Maintains the flow of communications between Global Quality and VCT teams.
  • Brings Quality issues to the VCT and assists with prioritization of projects and with key product decisions.
  • Supports the business continuity process including VCT strategy and BCP projects.
  • Reviews Proactive Product Quality Scans with the VCT and assures appropriate mitigating actions are defined there.
  • Prepare quality sections of Product Strategy and End-to-end Value Chain Mapping.
  • Participate in the F2F VCT meetings on PSR and VCM finalization and project prioritization.
  • Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
• Presents project updates to QM for Global Quality alignment.
  • Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.
  • Participates and actively engages on IMTs. Supports field/recalls as needed.
• Drives Decision making and Problem Solving:
  • Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
  • Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
  • Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
  • Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of medium risk, uncertainty and ambiguity.
  • Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.

Qualifications/Requirements:

• A minimum of a bachelor’s degree (or University equivalent) with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration.
• A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry.
• Knowledge in cGMP standards, policies and procedures.
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering.
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans.
• Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required.
• A Master’s degree or other advanced degree.
• Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing.
• Experience in technology transfer, process development and/or process validation.
• In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies.
• Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities.
• Experience in API and Drug Product stability.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Johnson and Johnson is committed to providing interview process that are inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$120,000-$207,000

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.