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Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!

OVERVIEW

Serving as a QA head, the Associate Director Quality Assurance provides strategic leadership and direction to the site’s Quality Assurance function, ensuring the highest standards of cGMP compliance, product quality, and data integrity across solid orals, sterile/aseptic manufacturing, testing, and release operations.

This role is accountable for establishing, maintaining, and continuously improving the Quality Management System (QMS) in alignment with US FDA (21 CFR Parts 210, 211, 820, and 11), EU GMP Part I and Annex 1, ICH Q-series (Q7–Q10), ISO 9001/13485, and client-specific quality agreements.

The incumbent serves as the primary Quality Assurance authority for the site, providing oversight for manufacturing, validation, and quality assurance activities, ensuring inspection readiness at all times, and acting as the principal liaison during regulatory and client audits. This is an on-site position based at our Whippany, NJ facility.

RESPONSIBILITIES

Lead, develop, and manage all aspects of the site Quality Assurance (QA) functions, including compliance, validation, documentation, and batch disposition.
Establish, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with global GMP standards and client requirements.
Serve as the Quality Management Representative (QMR) to ensure QMS performance reporting to executive leadership and regulatory authorities.
Foster a culture of quality, data integrity, and continuous improvement throughout the organization.
Ensure full compliance with US FDA, EMA, PMDA, MHRA, Health Canada , and other applicable regulatory authority requirements.
Provide strategic oversight of all regulatory inspections and client audits , acting as site host, spokesperson, and decision-maker for QA.
Ensure timely and effective CAPA management , deviation investigation , change control , and risk assessment processes.
Maintain awareness of evolving GMP and Annex 1 requirements , ensuring site procedures are proactively updated to maintain compliance.
Provide QA oversight of aseptic filling, formulation, media fill programs, and environmental monitoring .
Ensure validated and qualified sterile manufacturing operations, including cleanroom classification, equipment qualification, and sterility assurance validation .
Review and approve key documentation such as batch records, validation protocols/reports, SOPs, Master Production Records , and analytical test methods .
Oversee quality risk management , contamination control strategy (CCS) , and data integrity (ALCOA+) programs.
Oversee the supplier qualification and contract service provider management programs, ensuring vendors meet applicable GMP and quality standards.
Maintain active client communication regarding product quality, audit follow-ups, and/or regulatory commitments.
Review and approve quality agreements with clients, suppliers, and third parties.
Build, mentor, and lead a high-performing Quality Assurance team with a focus on accountability, empowerment, and regulatory compliance excellence.
Drive continuous improvement initiatives through metrics-driven performance reviews, trending, and management review programs.
Collaborate with cross-functional departments (Operations, Engineering, Business Development, Supply Chain, Product Development) to align business and quality goals.
Serve as the final quality assurance authority for product release decisions , ensuring all materials and finished products meet defined specifications and regulatory requirements.
Ensure robust control of GMP documentation, training, and change management systems .
Oversee quality management , validation lifecycle , and Annual Product Quality Reviews (APQRs) .

QUALIFICATIONS/SKILLS

Visionary leadership with a collaborative, results-driven approach.
Exceptional communication and presentation skills for regulatory, client, and executive interactions.
High integrity and decisiveness in managing compliance matters.
Strategic thinker with hands-on problem-solving ability.
Proven capability to manage multiple priorities in a dynamic, growth-oriented CDMO environment.
Ability to spend time in classified cleanroom areas in full gowning as needed.
On-site presence required to oversee operations, audits, and manufacturing quality activities.
Occasional travel to clients or supplier sites as required.

EDUCATION, EXPERIENCE AND LICENSING REQUIREMENTS

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, Microbiology, or related scientific discipline .
Advanced degree (Ph.D. or MBA) and/or ASQ Certified Quality Auditor (CQA) , Certified Quality Engineer (CQE) , or Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred.
10+ years of experience in the pharmaceutical or biotechnology industry , with at least 7+ years in a senior Quality leadership role , preferably within a sterile/aseptic CDMO or manufacturing site .
Deep knowledge of US FDA 21 CFR Parts 210, 211, 820, and 11 , EU GMP Part I and Annex 1 , ICH Q-series , and ISO 9001/13485 requirements.
Proven track record of leading regulatory inspections (FDA, EMA, PMDA, MHRA, Health Canada, etc.) and successfully responding to observations or warning letters.
Demonstrated success in building compliant quality systems for tech transfers, process validations, new product introductions, and lifecycle management .
Strong understanding of sterility assurance , cleanroom qualification , environmental control , and data integrity programs .
Experience in client-facing CDMO operations , including quality agreements, audits, and product lifecycle support.

Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.

Halo is an Equal Opportunity / Affidavitu employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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Position Summary:

This is a full-time salaried position

Based onsite out of Philadelphia, PA office

T?he

Associate Director, Quality Assurance

is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, improving activities related to process and support to business demands.

Our Philadelphia facility is our North American Center of Excellence for clinical supply packaging.

The Role:

Quality liaison for clients and internal customers; is expected to become the owner or escalation point for client requests/issues

Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus

Participate in Regulatory Inspections and Customer Audits, etc

Participate in site and customer meetings/communications and be directly involved in critical projects/issues

Establishes goals and monitors performance through monthly, quarterly, and annual summaries and metrics

Present summary data to site management on a regularly scheduled basis

Provide QA Technical recommendations based on trend analysis to eliminate future problems

Participates in project meetings to provide input with respect to compliance to cGMP requirements

Other duties as assigned

The Candidate:

Bachelor's degree in scientific discipline, chemistry, biochemistry, biology, microbiology, or chemical engineering, required

Minimum of 10 years' relevant experience in the pharmaceutical industry

Minimum four years of leadership/management experience with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives

Working knowledge of cGMPs regulations, required; prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)

Experience working with customers - Contract manufacturing experience, preferred

Prior experience working with quality control, or GMP manufacturing/packaging, preferred

Prior experience working directly with regulatory agencies and handling inspections, preferred

Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Why You Should Join Catalent:

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

152 hours of PTO + 8 paid holidays

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement

WellHub - program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career!

Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .\n","Associate Director, Quality Assurance

Position Summary:

This is a full-time salaried position

Based onsite out of Philad...",[84],["B","3105132812"],"Work at Catalent Inc","5 days ago","/jobs/3105132812-associate-director-quality-assurance","Phila, PA, United States","/jobs?keyword=Catalent+Inc","/jobs?location=Phila%2C+PA%2C+United+States",{"_65":66,"_67":85,"_69":86,"_70":87,"_88":89},"Phila","Phila, PA, United States, 19117","PA","postal_code","19117",["D",1774935288000],"Scientific Search","

Engaging Summary

My client — a fast-scaling biologics CDMO — is searching for a bold, detail‑obsessed QA leader who thrives where science meets execution. As Associate Director of Quality Assurance, you’ll be the guardian of GMP excellence, shaping quality operations that support cutting‑edge antibody development. If you’re energized by the pace of biotech, love owning QA systems end‑to‑end, and want to influence the full product lifecycle, this role is built for you.

Location

Emeryville, CA (Onsite)

Why You Should Apply

Lead QA operations in a high‑impact CDMO environment
Own batch review, lot disposition, QMS execution, and key quality systems
Partner cross‑functionally in biologics development and tech transfer
Competitive salary + strong benefits + onsite visibility
Shape Quality culture as the site continues expanding

What You’ll Be Doing

Maintaining site GMP compliance and documentation
Overseeing deviations, CAPA, change control, quality agreements
Leading batch record review & timely lot disposition
Supporting regulatory submissions and audits
Working closely with manufacturing, QC, facilities & external labs

About You

BS + 7 years pharma/biotech experience; 5 years QA
Strong biologics/GMP background
Skilled reviewer, communicator, and collaborator
CMOs/CTOs experience strongly preferred

How To Apply

Send resume to with Job # 19698.

#J-18808-Ljbffr","

Engaging Summary

My client — a fast-scaling biologics CDMO — is searching for a bold, detail‑obsessed QA leader who thrives where s...","Associate Director, Quality Assurance",[104],["B","2734318998"],"Work at Scientific Search","7 days ago","/jobs/2734318998-associate-director-quality-assurance","Emeryville, CA, United States","/jobs?keyword=Scientific+Search","/jobs?location=Emeryville%2C+CA%2C+United+States","/jobs?keyword=Associate+Director%2C+Quality+Assurance",{"_65":66,"_67":105,"_69":106,"_70":107,"_88":108},"Emeryville","Emeryville, CA, United States, 94608","CA","94608",["D",1775473200000],"Location:

Emeryville, CA (Onsite)

Engaging Summary

My client a fast-scaling biologics CDMO is searching for a bold, detail-obsessed QA leader who thrives where science meets execution. As Associate Director of Quality Assurance, youll be the guardian of GMP excellence, shaping quality operations that support cutting-edge antibody development. If youre energized by the pace of biotech, love owning QA systems end-to-end, and want to influence the full product lifecycle, this role is built for you.

Why You Should Apply

Lead QA operations in a high-impact CDMO environment\nOwn batch review, lot disposition, QMS execution, and key quality systems\nPartner cross-functionally in biologics development and tech transfer\nCompetitive salary + strong benefits + onsite visibility\nShape Quality culture as the site continues expanding

What Youll Be Doing

Maintaining site GMP compliance and documentation\nOverseeing deviations, CAPA, change control, quality agreements\nLeading batch record review & timely lot disposition\nSupporting regulatory submissions and audits\nWorking closely with manufacturing, QC, facilities & external labs

About You

BS + 7 years pharma/biotech experience; 5 years QA\nStrong biologics/GMP background\nSkilled reviewer, communicator, and collaborator\nCMOs/CTOs experience strongly preferred

How To Apply

Send resume to

ava@scientificsearch.com

with

Job # 19698.\n","Location:

Emeryville, CA (Onsite)

Engaging Summary

My client a fast-scaling biologics CDMO is searching for a bold, deta...",[116],["B","3145158469"],"19 hours ago","/jobs/3145158469-associate-director-quality-assurance",{"_65":66,"_67":105,"_69":106,"_70":107,"_88":108},["D",1775383200000],[124],["B","3158235369"],"1 days ago","/jobs/3158235369-associate-director-quality-assurance","Richmond, CA, United States","/jobs?location=Richmond%2C+CA%2C+United+States",{"_65":66,"_67":125,"_69":126,"_70":107,"_88":127},"Richmond","Richmond, CA, United States, 94875","94875",1072,"name","Hearst Television","agency","logo","slug","hearst-television","

Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

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