Director, Quality Control

Valid8 Financial, Inc.; California (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading life sciences company is seeking a Director of Quality Control to oversee laboratory operations and ensure compliance with regulatory standards. This role involves strategic planning, team leadership, and the development of quality metrics to enhance product quality and safety.

Benefits

100% healthcare coverage

401(k) match

Four weeks PTO

Generous time-off program for new parents

Access to educational opportunities

Qualifications

• 10 years management experience or 5 years with MS degree.
• Experience in pharmaceutical regulatory compliance.

Responsibilities

• Lead laboratory operations and quality control activities.
• Ensure compliance with regulatory body requirements.
• Develop long-term goals for Quality Control Management.

Skills

Leadership

Strategic planning

Knowledge of chemistry

Regulatory compliance

Education

BS degree in scientific or healthcare discipline

MS or Ph.D. in scientific or healthcare discipline

Tools

CLIA certified laboratory

Job description

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience’s mission! Take a look at this opportunity with our Quality Control team, which is seeking a passionate individual, to fill the role of our Director, Quality Control.

This position is responsible for providing the strategy and direction of Quality Control at Prolacta Bioscience as well as oversight of all laboratory-related activities at the facilities. This includes the Quality Control Operations, Stability, Method Development and Validation, and Clinical Laboratory units at Prolacta Bioscience. The head of Quality Control is responsible for ensuring that all laboratory operations comply with Prolacta Bioscience policies and the requirements of all major regulatory body agencies (e.g. FDA, PMDA, NYSDOH, CDPH, other International regulators, etc.). The Director, Quality Control, along with the Clinical Laboratory Director, oversees the Prolacta Bioscience Clinical Laboratory and ensures compliance with CLIA requirements. This position is part of the site leadership team and serves as a Management Representative.

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world’s leading hospital provider of 100% human milk–based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

For more information, please visit www.prolacta.com

How you will contribute
This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by…

· Leading day to day laboratory operations, manufacturing support, and related site quality control activities. The Method Development arm of QC will coordinate with the R&D department regarding required QC activities for developmental products.

Ensuring laboratory operations is supported by sufficient adequately experienced, trained, and equipped Quality Control management and staff to control and assure the purity, efficacy, quality and strength of product manufactured at the site.

Ensuring clinical laboratory is supported by sufficient adequately experienced, trained, and licensed clinical staff for raw material testing to assure the purity, efficacy, quality, and strength of product manufactured at the site.

Coaching, counseling and mentoring staff on issues relating to job activities and career development.

Providing strategy and direction on Quality Control related issues for the site. Independently identifies and initiates functional and cross-functional projects/task teams on a pre-emptive or as needed basis.

Promoting adherence to corporate philosophy and policies through actions and decisions.

Identifying new approaches, systems and/or technologies to improve quality control and productivity for both the functional and business unit. Support initiatives directed at the local level and internationally.

Developing and regularly reporting on metrics to demonstrate levels of quality and compliance and adherence to work plan/business objectives.

Developing and implementing long term goals and objectives for Quality Control Management to meet the demands of the business while maintaining operational quality and compliance of Prolacta Bioscience with applicable local and international policies and government regulations.

Managing cost of testing to meet standard cost targets

Serving as a liaison to Corporate Quality Management team to ensure the consistent application of accepted quality standards.

Providing technical expertise and leadership to the functional area and the business on issues of Quality and Compliance and represent the business on such issues involving GLP/GMP inspections and audits by regulatory agencies and other outside parties.

What you bring to the role

Requirements

BS degree in scientific or healthcare discipline, with 10 years of management experience or MS degree with 5 years of management experience

R. Ph. or Pharm.D. MS or Ph.D. in scientific or healthcare discipline or equivalent combination of education and related experience preferred.

Minimum 10 years management level experience in pharmaceutical regulatory compliance.

Qualifications

• Detailed knowledge of chemistry and manufacturing controls.
• Good general understanding of cross functional groups, i.e. Validation, Process Engineering, R&D, QC, QA, Production, FDA Regulations, GMPs, SOPs
• Knowledge or experience with a CLIA certified laboratory
• Strategic planning experience
• Experience with creating and managing a budget

How Prolacta benefits you

To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage on your first day and 401(k) match, we value our employees’ health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.

What else do you need to know

Location: City of Industry, and Duarte, CA

Schedule: Monday - Friday 8am to 5pm

Travel: 10% Domestic and International Travel

FLSA: Exempt

Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on www.prolacta.com . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.

EEO Statement

“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.

#LI-Onsite

Apply for this job

First name

Last name

Email address

Location

Phone number

Resume Attach resume

Attach another file Attach file

What is the name of your current employer?

What are your salary requirements? per hour

Are you authorized to work in the United States? Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?

Do you have any professional qualifications (PMP, MCSE)?

What is the highest level of education you’ve obtained? What is the highest level of education you’ve obtained?

Have you ever used another name? If Yes, is any additional information relative to enable a check on your work and educational record? If Yes, please explain:

How did you learn about this opening?

Desired Employment? Full-Time; Part-Time; Temporary

Do you have any relatives working here? If yes, who?

Have you ever worked for this Company before? If yes, give dates and position.

If hired, can you submit verification of your legal right to work in the U.S.? Yes No

Present or Last Employer; include contact number

Exact Reason for Leaving

Have you ever been terminated or asked to resign from any job? If yes, please explain circumstances:

May we contact your current employer? If no, please explain

We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process.

GENDER Male Female Nonbinary I do not wish to self-identify my gender

ETHNICITY American Indian/Alaska Native (Not Hispanic or Latino) Asian (Not Hispanic or Latino) Black/African American (Not Hispanic or Latino) Hispanic/Latino Native Hawaiian/Other Pac Island (Not Hispanic or Latino) White (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify

If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA.

Disabled Veteran Armed Forces Service Medal Veteran Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized Recently Separated Veteran

Veteran, but not one of the four protected classes above I decline to state my veteran status Not a Veteran

We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Don’t Have A Disability, Or A History/Record Of Having A Disability I Don’t Wish To Answer

Should be {http://www.linkedin.com/pub/[member-name/]x/y/z}or {http://www.linkedin.com/in/string}