Associate Director, RAQA, ANZ at Baxter International

Sydney, New South Wales, Australia

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Tertiary degree in Pharmacy/Science, or related fields (Postgraduate qualifications in business or related areas are advantageous)
Up to 15 years of experience in the pharmaceutical or medical device industry
10 years or more of developing Quality Assurance responsibility in pharmaceuticals and/or medical devices
5 years or more in a relevant leadership role (implied from experience cutoff)

Responsibilities

Provide leadership in planning and execution of ANZ regulatory strategies for new and existing products
Coordinate and lead regulatory and certification inspections as well as all communications with regulatory and certification agencies
Ensure adequate resourcing and direct activities of QA/RA professionals and delegates providing support to local business
Prepare, update, and implement regulatory operational plans to deliver desired regulatory outcomes
Oversee all quality related strategies, policy and process, optimization and ensure maintenance of quality system align with corporate and regulatory requirements
Manage regulatory deliverables throughout the product lifecycle
Lead regulatory policy shaping in partnership with Government Affairs colleagues
Monitor product quality, coordinate communication, and ensure corrective actions with manufacturers
Manage the ANZ Audit and CAPA systems
Prepare and submit required quality documents, exercising considerable judgment
Establish and implement policies for effective product regulatory submission preparation and management
Develop ANZ regulatory plans for new products and set standards for promotional activities
Ensure good communication with customers and authorities to maintain the company's quality image
Work effectively with local authorities, testing authorities, manufacturers, and suppliers to ensure product compliance
Ensure robust Management Review and internal audit processes for continuous improvement
Provide technical support in the investigation and handling of quality issues and customer complaints

Skills

Regulatory Affairs

Quality Assurance

TGA

Medsafe

MTAA

Pharmaceutical Regulations

Medical Device Regulations

RAQA

Regulatory Compliance

Strategic Planning

Leadership

Stakeholder Collaboration

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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