Job Application for Quality Manager - 503b cGMP Environment at Wedgewood Pharmacy

tags.new

At Wedgewood Pharmacy, we are dedicated to improving the lives of animals through customized medication and compassionate care. Every role in our organization contributes to helping pets live healthier, happier lives. We are a team driven by purpose, quality, and a shared commitment to animal health.

We are seeking a Quality Manager to join our team. In this role, you will help support our mission by ensuring high-quality execution of daily responsibilities, maintaining accuracy, and contributing to a collaborative environment focused on patient care and continuous improvement.

The Quality Manager is responsible for managing quality assurance and quality control processes and teams at the Albany 503b manufacturing facility. This includes oversight of all quality assurance and all quality control functions. This individual will participate in supporting and independently work through quality processes that reinforce the company’s values of customer focus, integrity, collaboration, and innovation while meeting the needs of our stakeholders and regulators. The Quality Manager leads and manages direct reports and ensures their activities occur in accordance with cGMP, USP 795, USP 797, State Board of Pharmacy regulations, Section 503B of Federal FD&C Act and company policies and procedures.

The Basics

Location: Albany, OH, Onsite
Job Type: Full Time
Schedule: Mon- Fri
Compensation: The base pay range for this position starts at $110K base plus an annual bonus commensurate with the individual's experience and qualifications.
Benefits: Eligible

How You Will Make an Impact

Prepare and/or review/approve controlled documents (e.g. SOP’s Batch Records, Specifications, Protocols, Deviation reports, OOS investigations)
Review and approve change controls ensuring adequate justification, impact assessment and implementation plan.
Review and approve executed validation documents ensuring specifications were met.
Assist in leading all regulatory inspections of the site, including inspections from FDA and state Boards of Pharmacy.
Create annual product reviews.
Review and approve all required product label changes.
Oversee communication and data exchange with all external laboratories regarding product testing status.
Oversee the quality of incoming materials.
Oversee the sample reserve program.
Support Vendor Management program including qualification and maintenance of vendors.
Ensure direct reports are efficiently and effectively allocated to support customer expectations and the needs of the business.
Participate in cross functional teams in preparation for regulatory inspections, quality agreements, internal and external audits, validation activities and special projects.
Provide quarterly metrics/trends to the General Manager and to the Quality Director.
Stay current with applicable laws, federal and pharmacy regulations, and company quality standards.
Contribute to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance.
Oversees Sterility Assurance

What We Are Looking For

Bachelor's Degree
10+ years’ experience in biotech/biopharma/medical device/pharma industry
7+ years’ working in progressively responsible positions in quality
7+ years’ experience managing staff and providing effective leadership to direct reports
Have held a quality role that included batch disposition determination
Have vast experience with 21CFR Part 11 compliant quality management systems.
Experienced in interfacing with regulatory agencies (e.g. FDA)
Have prior experience with QMS systems and implementation.
Have prior experience in auditing and managing API brokers/manufacturers, contract manufacturing organizations and or contract testing laboratories.
Sterility experience

What You’ll Love About Wedgewood

Competitive compensation and benefits
Opportunities for growth and career development
A supportive, team-first culture where your work matters
The ability to make a real impact on animal health every day
Medical, dental, vision and voluntary benefit coverages
Company Paid Life Insurance and disability coverage
401(k) retirement plan with generous company contribution
Paid time off that increases every year
Tuition reimbursement opportunities
Strong internal promotion and career development programs

Pay Range

$110,000 - $110,000 USD

Why We Do What We Do

At Wedgewood Pharmacy, your work has purpose. Every prescription you help prepare, support, or deliver contributes to improving the health and well-being of animals. We are passionate about what we do and proud to build a workplace where people feel supported, included, and valued.

Our Commitment to Inclusion

Wedgewood Pharmacy is an equal opportunity employer. We are committed to building a diverse and inclusive workplace where everyone can thrive.

Create a Job Alert

Interested in building your career at Wedgewood Pharmacy? Get future opportunities sent straight to your email.

First Name

Last Name

Preferred First Name

Country

Phone

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Address 1

Address 2

City

State

Select...

Zip Code

Pay Expectations Aligned

Select...

Will you now or in the future require sponsorship for employment work authorization?

Select...

Currently, or in the future, does your authorization to work in the United States involve Curricular Practical Training (CPT) or Optional Practical Training (OPT)?

Select...

Are you at least 18 years old or older?

Select...

Are you a high school graduate, or have you earned a GED?

Select...

I acknowledge that Wedgewood participates in E-Verify meaning Wedgewood will provide the federal government with my Form I-9 Emloyment Eligibility Verification to confirm that I am authorized to work in the United States. E-Verify is completed for all hires after offer acceptance. For more information, please visit the e-verify.gov website for an overview of the process.

Select...

Have you ever had a professional license denied, revoked, suspended, or otherwise restricted, conditioned, or limited or have you surrendered a professional license, been fined, placed on probation, reprimanded, disciplined, or entered into a settlement with a licensing authority in connection with a professional license you have held in any jurisdiction, or is any such action pending?

Select...

Have you at any time had an application for registration with the Drug Enforcement Agency (DEA) denied, had a DEA registration revoked, or surrendered a DEA registration for cause?

Select...

Are you available to work the hours as stated in the job posting?

Select...

Please tell us why you consider yourself a suitable candidate for this position. You should include examples of proven skills and relevant talents you would bring to this position. Also, include your motivation for seeking this position.

List any additional information you feel may be helpful to us in considering your application (e.g. professional trade, civic activities, and/or offices held).

Are you able, at the time of employment, to submit verification of your legal right to work in the United States?

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Wedgewood Pharmacy’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Select...

Are you Hispanic/Latino?

Select...

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Quality Manager - 503b cGMP Environment

Apply for this job

Voluntary Self-Identification

Voluntary Self-Identification of Disability