Director, Combination Product & Device PQM

Johnson & Johnson•Titusville, NJ

About The Position

We are searching for the best talent for Director, Combination Product & Device, Product Quality Management (PQM) to join our Quality organization located in Titusville, NJ; Raritan, NJ; Malvern, PA; or Horsham, PA. 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): Belgium, Switzerland and India - Requisition Number: R-068981 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. About Innovative Medicine 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 The Director, Combination Products & Device, PQM provides Quality Engineering & Quality Assurance leadership for dynamic portfolio of Drug-Device combination products in J&J Innovative Medicine. The scope spans end-to-end product cycle including new product development pipeline and lifecycle management of marketed combination products with emphasis on Design Control & Combination Product Quality Engineering. The Director, Combination Product & Device, PQM works on problems of diverse scope involving the application of global & regional combination product quality and compliance frameworks including 21 CFR Part 4, FDA QMSR, EU-MDR etc. The individual serves as a subject matter expert on global Combination Product Quality and Compliance aspects, provides quality oversight and guidance, training and consultation or medical device and combination products quality systems and quality requirements. The individual is acutely tuned into the external regulatory landscape, keep abreast of the latest trends and actively interact with and influences internal and external stakeholders.

Requirements

Bachelor’s degree in scientific or technical discipline is required.
Master’s or PhD preferred
At least 15 years of experience in Pharmaceutical, Combination Product and/or Medical Device industry.
Multifunctional background preferred
Deep understanding of Combination products and associated regulatory and quality requirements
Understanding of business & technical needs and can relate these to scientific concepts
Experience with Quality Systems, ISO 13485, ISO 14971, EN 62366, cGMP, and ICH Requirements
Knowledge of Devices, Biotech and/or Pharma Manufacturing required, particularly in Design Controls and Risk Management
Demonstrated strong stakeholder management skills
Prior leadership of and participation in projects across functions & sites
Strong Project Management and Communication Skills
Strong Decision-making skills: Makes decisions independently on problems and methods.
Excellent technical writing skills; experienced in SOPs, protocols, reports.
Conflict Management and facilitation skills required.
Fluent in English
Ability to write routine technical & quality documents and correspondence or procedures using original, prescribed, or innovative techniques or styles.
Ability to speak, present and/or respond before groups of customers, employees, Regulatory agencies, clients, and to address common inquiries.

Responsibilities

Provide strategic direction for the Johnson & Johnson Innovative Medicine Combination Product & Device Development initiatives while ensuring design control procedures are harmonized, integrated, understood & executed by key business partners across multiple departments and sites.
Drive innovative thinking along with a disciplined approach for the rapid, compliant, high-quality development, transfer and lifecycle management of new drug device combination products across multiple sites while ensuring business and regulatory requirements are achieved.
Take ownership of achieving and maintaining a robust compliance profile for Durg Device Combination Products across the JJIM development and supply chain sites. This includes proactive identification of risks, driving mitigation/remediation activities and supporting inspection readiness activities.
Provide functional management to a team of Quality Engineers supporting new product development and lifecycle management of drug-device combination products.
Act as a Combination Product & Device Quality Subject Matter Expert in global Health Authority inspections.
Oversee the revision of site / functional procedures related to Combination Product Development Process & Design Control and provide training programs in the area of Combination Products.
Act as a Qualified Trainer for the deployment of these and any other applicable training programs.
Develop and apply advanced knowledge of advanced quantitative analysis, statistics, DoE etc.
Support asset evaluation for licensing and acquisitions activity.
Carry out duties in compliance with all local, state, and federal and international regulations and guidelines including FDA, EMA, EPA, OSHA, and global health authorities as applicable.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits