Global Finished Goods Packaging Development Manager

Job Summary

The Global Finished Goods (FG) Packaging Development Manager will develop new global content and packaging/labeling materials in support of new product launches and base business projects as well as accountability for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through Change Control Record (CCR) processes is carried out in compliance with relevant standards and regulations.

The Global FG Packaging Development Manager will be responsible for overseeing a cross functional collaboration with appropriate teams to ensure packaging and labeling continuity and compliance to country requirements. This position will also perform any finished goods packaging related deviations and investigations.

This position may also be responsible for the support for all departments at Prolacta Bioscience within the regulated environment as applicable to state, federal regulation, and international standards (i.e. FDA, EU, PMDA, MOH) for finished goods packaging.

Primary Duties and Responsibilities

· The Global Finished Goods Packaging Development Manager will develop global packaging/labeling materials (including tamper evident/resistant closure such as neckbands) in support of new product launches and base business projects as well as accountability for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through Change Control Record (CCR) processes is carried out in compliance with relevant standards and regulations

· Partner with vendors on translation projects, including internal and external communication, to ensure timely execution. Identify translations issues and determine resolutions

· Perform root cause investigations for any finished goods packaging or labeling nonconformances and product complaints

· Develop solutions to a variety of problems of moderate scope and complexity

· Initiate supplier corrective action reports (SCAR) for any finished goods packaging related suppliers and collaborate with Quality Compliance for timely resolution

· Oversee continuous process improvements of the Finished Goods Packaging Development Program

· Manage cross functional relationships and internal customer service between departments to support projects and initiatives.

· Responsible to identify, analyze and develop improvements in productivity, quality, client relationships to support company goals.

· Familiarity with and the ability to apply a variety of quality concepts, practices and procedures

· Participates in determining objectives of assignment; arranges own activities in accomplishing objectives

· Utilize electronic Quality Management Software for Quality System processes

· Contributes to the completion of more complex organizational projects and goals

· Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

· Other duties as assigned

Job Requirements and Qualifications

· Bachelor’s degree in a technical discipline

· 5 years of related experience, preferably in the biologics or infant formula industry with a minimum of 3 years of finished goods packaging development experience.

· Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 110 and 117 is highly desired.

· Any international regulatory packaging and labeling requirements knowledge preferred

· Direct experience with regulatory inspections required.

Other Knowledge, Skills and Abilities

· Moderate understanding of domestic and global development and implementation of labeling

· Moderate understanding of medical and/or pharmaceutical regulations and standards

· Moderate knowledge of medical device documentation development activities

· Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness

· Ability to evaluate change package and make decisions on resource consumption

· Ability to work without supervision

· Effective relationship building skills

· Ability to produce and present clear, concise and professionally written communications and presentations

· Positive attitude and motivation

· Ability to operate in a complex matrix environment

· Visionary and forward-thinking

· High level of business acumen

· Project management

· Strong PC skills, Adobe, MS Outlook, Word, etc.

· Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously

· Strong attention to detail

· Strong Critical thinking and decision making skills

· Strong business ethics

· Good working knowledge of FDA regulations relating to Food, Infant Formula, Pharmaceuticals or Biological Products.

· Ability to interpret International standards for new market entry label and packaging requirements

· ISO Implementation and or Certification experience is a plus.

· Lean (Six Sigma) certification is a plus.

Work Environment (Location, travel, shift, on-call, etc.)

Location: This position is located in City of Industry, CA. but may support additional locations in the future.

Travel: 10%

Shift: Day Shift

Physical Requirements

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Stand

Walk

Sit

Talk or hear

Use hands to finger, handle or feel

Climb or balance

Stoop, Kneel, crouch or crawl

Reach with hands and arms

Taste or smell

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Up to 10 pounds

Up to 25 pounds

Up to 50 pounds

Up to 100 pounds

More than 100 pounds

Direct Reports

N/A

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to thisfication. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel sofied. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.