Entries tagged with “quality” from BiotechPharmJobs.com

Job Description:

Job Title: Sr. Tech Manager
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Sr. Tech Manager for one of its client's located in South San Francisco, CA.

The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of manufacture of small molecule API and Drug Product at contract manufacturing organizations.

Responsibilities:

• Build strong relationships with both internal operations units and external CMOs and partners.
• Participate in due diligence visits to assess CMO's Quality Systems for processing of investigational / commercial medicinal products.
• Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled. Ensure product-specific requirements are met.
• Ensure that manufacture and testing of clinical supplies of the client's small molecule & ADC products at contract manufacturing organizations (CMOs) is conducted in accordance with cGMP.
• Follow up on any corrective actions identified as a result of the client's audits.
• Write and execute CMO facility/process GMP commissioning plans to ensure all quality requirements are met prior to manufacturing.
• Review and approve master batch records for compliance to clinical trial protocols, regulatory filings, pertinent product requirements and cGMP compliance.
• Perform person-in-the-plant activities as required during GMP manufacturing.
• Review batch records and assess deviations and investigations.
• Review CMC sections of regulatory filings.
• Participate in the design, implementation and maintenance of quality systems for small molecules for execution of the above functions.

Skills:

• Demonstrated working knowledge of Quality Assurance and manufacturing principles.
• Sound knowledge of US cGMPs and an ability to apply sound judgment and decision-making skills in order to evaluate product release is necessary.
• Working knowledge of worldwide cGMP regulations desired.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and negotiation skills.

Education:

• At least 5 to 10 years relevant pharmaceutical experience with small molecules, experience in solid dosage form manufacturing is desired.
• At least 4 years direct experience in quality assurance for pharmaceutical operations.
• BS/BA in a relevant scientific discipline or equivalent

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Associate Director
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Associate Director for one of its client's located in South San Francisco, CA.

Responsibilities:

• Accountable for the development and deployment of the External Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the global Small Molecule product development effort at Roche (PTD, pRed and gRed).
• Accountable for all aspects of Quality related to these CMO's to include: Quality Systems, Product Quality Operations, Assay Qualification and Validation, cGMP Compliance, Risk Management, and Inspection Readiness.
• Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche's reputation as a reliable, high quality supplier of IMP products.
• In collaboration with other PTx, gRed and pRed functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements.
• Responsible for management of risk, through proactive risk management tools and approaches for each CMO within the Roche Small Molecule Development Network.
• Accountable for the management of Quality and Compliance within the External Quality Small Molecule Development group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Skills:

• Minimum 12 years of direct work experience in the pharmaceutical industry.
• Demonstrated leadership experience in a Pharmaceutical Development environment.
• Strong knowledge of cGMP and Quality requirements for various early and late phase clinical stages.
• Experience technical aspects of pharmaceutical manufacture (Starting materials, API, Solid Dosage Form, and Packaging).
• Experience in reviewing and approving IND, IMPD and NDA documentation for submission to health authorities.
• Demonstrated leadership and execution of Quality Operations and processes. Established track record of Quality and Compliance decision-making.
• International experience working with ex-US manufacturing, EU QP's, and ROW cGMP Sophisticated negotiation and influencing skills.
• Strong leadership and communication skills.

Education:

• Minimum BS degree. MS, PhD in chemistry or chemical engineering.

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

We at MAKRO deliver custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known IT and Life Science Organizations throughout United States.

Our vision is to become a most reliable "connector" between our clients and the Talent pool i.e "YOU."

Sr Clinical Data Coordinator
South San Francisco, CA

Description:
• Maintain a project-level perspective on data management issues, activities and deliverables
• Manage projects resourced externally via contract research organizations or corporate partners
• Develop Data Quality (DQ) Plans (specification of the data quality checks that will be performed by Clinical Data Management)
• Perform discrepancy management (timely review and resolution of all relevant discrepancies, close interaction with project clinical research associates)
• Develop CRFs by interacting with other functional area representatives and managing the physical development of CRFs through Forms Design

Requirement:
• Strong problem solving skills
• Oracle Clinical experience is required, EDC is a plus BA/BS 2-4 years of relevant experience.

To apply, please forward your updated MS Word resume, including availability (if you are authorized to work in the United States for any employer), location and position preferences to glenn.davis@makroscientific.com ******** for review before we speak. or contact our Recruitment Helpdesk at 973-679-5005

Also if you have any friends or colleagues, working on similar skill set, kindly refer them as well as there are multiple open positions.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Quality Assurance Manager

Urgent requirement for one of our top clients located in Emeryville, CA.

Description:
Perform a variety of activities to ensure compliance with applicable regulatory requirements and facilitate the management of third-party contract manufacturing organizations. Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs) for pharmaceutical, biotech and drug/device combination products. Author, edit, review, and approve policies, SOPs, and guidance documents. Manage and administer processes within the company's Quality System. Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, technical complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products. Lead or assist compliance audits (GMP, GLP, GCP, Internal and Supplier/External). Work with R&D as QA representative during new product start-ups, and identify routine checkpoints for new products and processes. Contribute to the completion of CMC sections of regulatory submissions. Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials.

Requirements:

Bachelor's or Master's Degree in a relevant scientific discipline with 5+ years demonstrated QA experience in a pharmaceutical or biotech company. Prior compliance work with sterile product, aseptic manufacturing processes, or drug/device combination products is highly desirable. Must have an understanding and application of FDA regulations and guidances, QA principles, concepts, industry practices, and standards.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. QAM_1508, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Manager of BDMP, Quality and Training

Urgent requirement for one of our top clients located in Irvine, CA.

Position Description:
Develops and trains to BDMP SOPs, WIMs, training material and other controlled documents. Applies regulatory ICH, GCP, and ISO quality system requirements to ensure appropriate SOPs, WIMs, and processes are in place and are adequately controlled and implemented within BDMP. Responsibilities are as follows: Participates in the development, training, and maintenance of BDMP controlled documents to ensure global adherence to Good Clinical Practices (GCPs) and related regulations and guidelines. Acts as liaison on teams with other departments, such as Clinical Quality and Training, Clinical Research, RDSIS, WWQA, and Global Regulatory Compliance. Supports ISO-13485:2003 Certification Activities, including complying with WWQA standards, training BDMP, coordinating all preparatory activities within BDMP, participating in the audit and response.

Requirements:

A BS/BA degree, or equivalent experience, in a science, math, or computer science discipline, with an additional 8 years experience in a relevant field; or an MS degree, or equivalent experience, with an additional 6 years experience. A minimum of 4 years of experience directly related to a BDMP-technical area, or 2 years of experience directly related to a BDMP-technical area and 2 years of BDMP or Clinical GCP training experience.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. MBQT_1108, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.