Original - (if this works)
Below is a list of our current openings. If you have any referrals please contact Wirth & Associates; we are available to help you with your next search.
Thank you for your time.
Director, Quality Control
Florida
140K plus Bonus/Stock
Develop, implement and direct the Quality Control program. Ensure adherence to all cGMP policies and corporate standards. Maintain quality through internal and external inspection of raw materials and finished items purchased, as well as production operations and processes.
Bachelors degree in Analytical Chemistry or similar discipline required. Masters or PhD preferred. Ten or more years professional experience with management responsibilities within pharmaceutical Quality Control.
QA Director - 066E-102010-99p
Southern CA
150K Plus Bonus (E of LA in low COL area for CA)
Solid dose bkgd Required.
Mfg facility of 500+
Manager, Quality Engineering 034J-102222-9C
Mid South
$100-110K + Bonus
This person will be responsible for design of quality systems to support compliance and R&D quality for a rapidly-growing OTC drug/device manufacturing operation of 500 people. There will also be corporate-level responsibility for implementation of these same types of systems at other plants.
Specific responsibilities include oversite of the supplier quality program, regulatory compliance, statistical/DOE support, design controls for R&D QA, testing methodology, supplier metrics and certification, CAPA, investigations, documentation, etc.
Position requirements include a BS degree in a technical or engineering discipline, supervisory/managerial experience within a drug or medical device QE environment, grass-roots quality systems/engineering systems design and implementation, and a knowledge of the above-mentioned functional areas. ASQ or Six Sigma certifications are a significant plus. This client offers advancement potential well-beyond that of traditional "Big Pharma" in this economic environment.
Quality Assurance Supervisor - 044J-110210-9C
Texas
$75-90,000 + 5% bonus
This is a wide-ranging position that will supervise a group of eight quality associates in the areas of software/facilities/equipment/process validation, compliance to CGMP and ISO 13485 standards, design controls/risk assessment, investigations/deviations, CAPA, and allied areas for a world-leader in Class II/III medical devices. Qualified candidate must have a BS degree minimum in an Engineering or Scientific discipline, prior QA supervision experience within the medical device industry and generalist experience in the above-mentioned areas of responsibility. This is a high-priority opportunity offering excellent visibility and growth potential.
Director, Finance
PA
Preparation of revenue related accounting analyses including the development of sales reserves and royalty calculations to facilitate timely and accurate financial statements, including supervision of related alliance accounting group.
Additional responsiblitlies as necessitated by business activities, including support of acquisition-related efforts.
Qualifications:
Bachelor's of Science (BS) in Accounting or related field required
7+ years of financial accounting experience with a concentration in the pharmaceutical industry required
4+ years in public accounting preferred
CPA preferred
Sr. Director Quality Systems - 022J-082610-9C
$200-230K + 25% bonus range.
Responsible for compliance and remediation activities for a client base that includes global leaders in the Pharmaceutical and Medical Device industries. These activities will include CAPA, 483 responses, Consent Decree remediation, Quality Systems implementation, Risk Assessment, Design Controls, PAI's, FDA audits, Supplier Quality Systems, internal and external auditing.
Principal Project Engineer
Central Sunbelt
$100-115,000 + 12% bonus
Will be responsible for complete project management of facilities and equipment initiatives to include specification, selection and qualification of high speed packaging equipment, Water For Injection, Steam in Place/Clean in Place, HEPA filtration, HVAC, etc., as well as facilities construction and rennovation projects for various manufacturing areas of the plant. These projects will range in size from $1MM to $15MM. Qualified candidates will have a BS degree minimum in an engineering discipline and at least eight years pharmaceutical industry project engineering experience, some of which must have been in a sterile product environment. This position offers exceptional visibility and advancement potential
Packaging Equipment Engineer - 077J-092110C
We need experience designing and installing high speed packaging equipment for tablet/solid dose products and this must include blister packaging.
Our client is a world-leader in branded pharmaceutical products with operations around the globe. We are seeking a Senior Packaging Equipment Engineer to work in one of their largest solid dose operations in the US. This individual will be responsible for specification, design, selection, installation, validation and commissioning of high-speed packaging equipment. The qualified individual will have a BS degree minimum in an Engineering discipline and at least three years of pharmaceutical project engineering experience providing technical expertise for high speed packaging equipment, to include blister packaging. Preferred qualifications include five or more years experience, Six Sigma Certification, Lean Manufacturing experience, etc. Also required is good project engineering experience managing projects from start to finish.
Quality System Manager - 156J-091510-C
Upper Midwest
$100,000
This position will establish and implement global quality strategies and systems encompassing the entire product life cycle in accordance with Company and regulatory requirements. The systems are to include change control, document control, internal auditing, complaint handling, noconformance/CAPA and regulatory compliance. The systems will need to be in compliance with domestic and international cGMP requirements for cosmetic, medical device, and over the counter drug products.
perspective. A BS degree is required with at least 5-10 years of experience in consumer product/OTC/medical device/pharmaceutical product QA.
Manager of Process Engineering - 10A-062410-01D
$140-160K plus bonus
San Francisco - Bay Area - Local Candidates only.
Bachelors Degree in Engineering, Science or related technical field
12 years of experience with significant experience in Pharmaceutical or Biotech industry in the areas of the Fermentation, Media Prep, Buffer Prep, Recovery, CIP or Clean Utilities
P.E. registration highly desirable
Solid knowledge of cGMP requirements, aseptic processing (including systems and equipment) and FDA regulations
Principal Packaging Engineer 023J-060110-C
Central Sunbelt
$100-115,000 + 14% bonus
Key is pharma/device packaging engr experience and specifically must have strong plastics experience to include injection/blow molding.
Manager, Manufacturing Quality - P051710-TWE1
NC
140K + bonus
Leads and manages the Manufacturing Quality function for the Site to assure the quality of product manufactured at the site meets patient needs and customer expectations, and is produced in compliance with company quality standards and all applicable regulatory requirements.
Preferred Experience and Capability
• B.S. in a technical discipline (Chemistry, Biology, Microbiology, Engineering, Pharmacy, etc.)
• M.S. (strongly preferred)
• A minimum of 5-7 years of increasingly responsible quality/technical service experience, ideally in an aseptic pharmaceutical manufacturing environment. Experience should encompass all aspects of manufacturing processes including standards definition, process validation, training, monitoring, investigations, product release, etc.
Quality Control Lab Manager J0156-091110C
Central Sunbelt
$120,000 + 18% bonus
This is a leadership role overseeing a QC Chemistry laboratory group of three direct reports and a total department of 20 people tasked with oversite of testing of raw materials, in-process and finished product, product release, stability, methods development and validation, equipment calibration and maintenance, methods transfer and the departmental budget. Qualified candidates will have at least eight years of pharmaceutical industry experience in quality control, at least three of which must have been in a supervisory or managerial capacity, BS degree minimum in Chemistry or closely-related and some experience with sterile/aseptic dosage forms. Client is a world-leader and this is a visible position.
Director, Quality Assurance 095-L062110-D
50% travel, market salary, bonus, stock, stock options.
Must have GCP, GLP, GMP. Parenterals highly desired.
The position involves direct oversight of quality assurance activities for drug products in clinical trials, study compliance with cGCP and corporate SOP’s, and then commercialization. Responsible for development and implementation of sound quality strategies for the company’s oncology products. Serve as liaison to the FDA and appropriate Regulatory branches. Oversight responsibilities include all GCP, GLP, GMP and quality assurance/control activities. As the Sr. Quality employee, ensure that all aspects of the quality program adds value to the Company’s mission to develop and commercialize ethical therapeutics.
Proven direction and leadership for the maintenance and on going development of the Company’s Quality System; ensuring compliance with the intent and letter of applicable sections of the CFR
Manager, Production 055-L062110-D
SVP company, NC.
Must have SVP, including sterile filling. Terminal sterilization is not good enough.
Base to ~ $100K, bonus, relocation.
POSITION SUMMARY
Responsible for the management of all manufacturing activities for the sterile filling business unit. The direct reporting staff includes the following: Compounding Supervisor, Fill/Finish/Lyophilization Supervisor,
Component Preparation Supervisor. All activities in this business unit are overseen by this position
