Grifols Veterans Jobs

Job Information

Grifols Shared Services North America, Inc Technical Manager, Labeling Development NAT in San Diego, California

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Technical Manager, Labeling Development - NAT

Summary:

The Technical Manager for Labeling Development NAT (Nucleic Acid Testing) is responsible for all labelling such as Packaging, Instructions for Use, and Operator Manuals. The position manages a technical team of writers as well as package and label designers. The Manager is responsible for coordinating and managing the implementation of regulatory labeling requirements and new product labeling. The role reports directly to the Director of Manufacturing Support and requires an elevated level of independence and interdepartmental cooperation, including extensive interaction with regulatory colleagues worldwide. The Manager, Labeling NAT is a decision maker & creator with high visibility and great opportunity for growth.

Why Grifols:

Our sustainable growth strategy allows this role to work in a flexible environment with the stability of a multinational, global acting company. The work environment is characterized by an open leadership style and an open and supportive culture that encourages innovation and continuous improvement by empowering individuals to make positive changes.

Your primary responsibilities:

  • Coordinate department activities to meet interdepartmental priorities.

  • Review and approve document change requests for labeling materials ensuring compliance with ISO, cGMP, and FDA guidelines.

  • Own and maintain product labels, specifications, standard operating procedures, package inserts, guides, instrument and software operator’s manuals, document plans, scientific materials, marketing materials, etc.

  • Manage team (includes training, development, and performance reviews) of technical writers and package and label designers.

  • Manage and coordinate the labeling function for new & existing products as needed. This includes interfacing with OEM partners, suppliers, and translation providers.

  • Manage quotes and purchase orders for translation providers.

  • Assist department in audits (FDA, ISO, partner, internal).

  • Assist in the development of product labeling strategies and processes and implement them.

  • Ensure a high level of quality, clarity, and consistency for all documents. Identify unclear, inappropriate, incomplete, or inaccurate descriptions and procedures, and provide solutions in a timely manner.

  • Manage reviews and approvals from a variety of departments (Quality Assurance, Regulatory Affairs, Marketing, Product Support, etc.).

  • Continually improve formats, templates, and procedures. Identify areas for improvement (e.g., processes, styles, formats), and execute continuous improvement initiatives.

  • Represent the department on project teams to determine project and document requirements.

More about us, benefits we provide you:

  • Salary in line with the market as well as an annual bonus target

  • 40% remote work option, flexible working hours

  • Free parking

  • Paid sick leave, paid vacation

  • Professional development opportunities (training, career development)

  • Gym pass, Employees perks program

  • 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)

  • Health insurance: Medical, Dental, Vision

  • Travel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability Insurance

  • Health Savings Account, Flexible Spending Account

  • Critical Illness, Accident, Hospital Indemnity coverages

  • Adoption benefits

About you:

Knowledge, Skills, and Abilities we are looking for

  • Working knowledge of cGMP/GLP, proficiency in Microsoft Office and Change Control

  • Ability to communicate with cross-functional partners effectively and actively (e.g., Supply Chain, Regulatory, Planning)

  • Ability to train personnel

  • Good organizational skills and strong attention to detail

  • Team oriented, attentive, and willing to learn new processes

  • Demonstrated technical writing skills

  • Ability to write, review, mark up, and format documents and labels

  • Demonstrated ability to multitask, prioritize, and complete goals

  • Demonstrated sound technical knowledge and good independent judgement

  • Strong leadership skills and ability to operate independently

  • Proficiency in Adobe FrameMaker, MadCap Flare, Tharo EASYLABEL or other editing software preferred

  • Familiarity with documentation management systems used in regulated environments

Education and Experience we require for this role

  • Bachelor's degree preferably in English or Technical Communication, or Certificate in Technical Writing

  • 4+ years of experience writing for a technical audience in a variety of styles, or equivalent combination of education and experience

  • 2+ years of experience managing a small group

  • Experience working on cross-functional teams and working in a regulated environment

  • Advanced proficiency in Adobe FrameMaker, MS Word, and Adobe Illustrator preferred

  • Strong written and oral communication skills

  • Demonstrated ability to work independently, according to strict schedules, and in a team environment, and to identify areas for improvement and provide solutions

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands

May require flexibility to work a variable schedule.

May require some travel (10%).

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed

Req ID: 490029

DirectEmployers